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65182Tuesday, September 19, 2000 Rules and RegulationsDEPARTMENT OF JUSTICEImmigration and Naturalization Service8 CFR Part 214[INS No. 1811-96]RIN 1115-AE61Habitual Residence in the Territories and Possessions of the United StatesAGENCY:

Immigration and Naturalization Service, Justice.

ACTION:

Final rule.

SUMMARY:

This final rule amends the Immigration and Naturalization Service (Service) regulations relating to the rights and limitations of habitual residents in the territories and possessions of the United States under:

• The Compact of Free Association between the United States and the Government of the Republic of the Marshall Islands and the Government of the Federated States of Micronesia; and

• The Compact of Free Association between the United States and the Government of Palau.

This amendment defines the rights and limitations of nonimmigrant habitual residents of the territories and possessions of the United States, other than American Samoa and the Northern Mariana Islands, who were admitted to those territories or possessions pursuant to the provisions of those Compacts. The final rule establishes a policy that protects the rights of both habitual residents electing to reside in United States territories and possessions and the citizens of the territories and possessions.

SUPPLEMENTARY INFORMATION: BackgroundWhy Are We Issuing This Regulation?

Public Law 99-239 approved the Compact between the United States and the Government of the Republic of the Marshall Islands and the Government of the Federated States of Micronesia, and Public Law 99-658 approved the Compact between the United States and Palau (collectively, Compacts). Under the Compacts, the majority of citizens of these newly formed states (parts of the former Trust Territories of the Pacific Islands, now called the freely associated states (FAS)) became eligible to enter, live, work, and be educated in the United States and its territories and possessions without regard to sections 212(a)(5)(A) and 212(a)(7) (A) and (B) of the Immigration and Nationality Act (Act), formerly sections 212(a) (14), (20), and (26). Section 141(a) of the Compacts. Both Compacts, at section 141(b), provide that the right of citizens of the FAS, who were admitted to the territories or possessions of the United States pursuant to the provisions of the Compacts, to establish habitual residence in a territory or possession of the United States may be subject to nondiscriminatory limitations.

The Service interprets section 141(b) of the Compacts to the effect that citizens of the FAS who enter the territories and possessions of the United States pursuant to section 141(b) of the Compacts are subject to limitations not only at the time they establish their habitual residence but for the entire duration of their habitual residence. The negotiators of the Compacts realized that while the economy of the island territories was fragile, the vast majority of the FAS citizens would actively participate in and be beneficial to it. On the other hand, there would be some who would not be gainfully employed or who would even engage in welfare fraud and thus become a burden on the territorial economy. Section 141(b) is directed at such entrants from the FAS. It is immaterial for the territorial economy whether this burden exists at the time when the FAS citizen first established his or her habitual residence in the territory or whether it occurs at a later time. The Service cannot attribute to the parties concluding the Compacts an intent that, once a citizen from the FAS first establishes his habitual residence in a territory or possession, he or she is immune from the future imposition of the limitations envisaged by section 141(b). The Service therefore reads the word “establishment” as necessarily including “maintenance,” and uses that word accordingly in this rule.

Section 643 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, Public Law 104-208, requires the Commissioner of the Immigration and Naturalization Service to issue regulations regarding the “rights of ‘habitual residence’ in the United States” under the terms of the Compacts.

What Is a “Habitual Resident”?

“Habitual resident” refers to an individual who is an FAS citizen who has been admitted to a territory or possession of the United States (except the Commonwealth of the Northern Mariana Islands or American Samoa as long as the Act has not been made applicable there) pursuant to section 141(a) of the Compacts, and who occupies in such territory or possession a habitual residence as that term is defined in section 461 of the Compacts, namely, a place of general abode or a principal, actual dwelling place of a continuing or lasting nature, including physical presence for a cumulative total of at least 365 days, and who is not a: (1) Full-time student under the Compact provisions; or a (2) dependent of a resident representative as described in section 152 of the Compacts. Since the term “habitual resident” requires that the person have entered the United States pursuant to section 141(a) of the Compacts, the term does not apply to FAS citizens whose presence in the territories or possessions is based on an authority other than section 141(a), such as members of the Armed Forces of the United States described in 8 CFR § 235.1(c), persons lawfully admitted for permanent residence in the United States, or persons having nonimmigrant status whose entry into the United States is based on provisions of the Compacts or the Act other than section 141(a) of the Compacts.

What Does This Regulation Accomplish?

This regulation is intended to define the rights of and limitations on habitual residence under the Compacts. In particular, the limitations relate to grounds for the possible removal of a habitual resident from the United States. The increasing presence of citizens of the FAS in the territories and possessions of the United States requires action to ensure that the benefits to the citizens of the FAS of employment and education in the territories and possessions, and the economic benefit to the territories and possessions of their presence are maintained, while simultaneously minimizing the impact on the territories and possessions resulting from granting unlimited access of such FAS citizens.

Where Does This Rule Apply?

This rule applies to habitual residents living in the territories and possessions of the United States to which the Act applies. These territories and possessions are at present Guam, the Commonwealth of Puerto Rico, and the American Virgin Islands.

This rule does not apply to FAS citizens residing in American Samoa or the Commonwealth of the Northern Mariana Islands, as long as the Act does not apply to them, or to FAS citizens residing in the fifty States or the District of Columbia.

Did the Service Publish a Rule Prior to Issuing This Final Rule?

On June 4, 1998, the Service published a proposed rule at 63 FR 30415. Written comments were to be submitted on or before August 3, 1998. The Service received three comments. The following is a discussion of the public comments and the Service's responses.

Discussion of Comments

All commenters expressed concern with the proposed definition of “dependents,” in particular, limiting dependents to an unemployed spouse, parents and unmarried children under 21 years of age. In the opinion of one commenter, this ignores the realities of family life in the Pacific Islands. However, it would not be workable to include distant relatives and family friends in the definition of “dependents,” as the writers advocated. In addition, the need to minimize any increase in social service expenditures by the territory and possession governments on behalf of habitual resident dependents renders the above-noted definition necessary.

One commenter recommended that the poverty guidelines established by the Department of Health and Human Services (HHS) that are required of the family unit be made applicable to the single individual with no family. Under the proposed rule, only 40 hours of “gainful employment” each week, regardless of his or her salary, were required of such an individual. Another commenter suggested striking altogether the requirement that the financial resources of the family unit meet or exceed 100 percent of these poverty guidelines. Another suggestion involved adjusting the HHS official poverty guideline standard to reflect the actual circumstances in Guam.

The Service lacks the needed expertise in matters relating to determining poverty guidelines to make meaningful adjustments to the HHS official poverty guidelines so as to reflect the actual circumstances in Guam, the territory most affected by this rulemaking. By incorporating the requirement that a habitual resident be “self-supporting,” however, the standard becomes based on the ability to financially support oneself with regard to local conditions. Further, “self-supporting” is defined in the final rule as either: (a) Having a lawful occupation of a current and continuing nature which provides 40 hours of gainful employment each week, without regard to the actual income or size of the family (for part-time students in college or institutions of higher learning the 40-hour requirement is reduced by three hours for each college or graduate credit-hour of study); or (b) in the case of a person employed for less than 40 hours a week or not at all, having lawfully derived funds that meet or exceed 100 percent of the official poverty guidelines for Hawaii for a family unit of the appropriate size as published annually by HHS. This approach provides what the Service views as a simple, fair, and flexible standard consistent with the Compacts.

All commenters voiced concern over adequate enforcement procedures. The writers suggested implementation of a registration system financed from revenues collected from the Service operation on Guam. These commenters wrote that the Service collects more revenue via fees than it expends in fulfilling its statutory obligations on Guam. However, the Service notes that, with the exception of a $6 Inspections user fee that all arriving persons pay upon entering Guam by air, immigration fees collected by the Service within Guam are not retained by the Service but are turned over to the Treasurer of Guam, pursuant to section 30 of the Organic Act of Guam, 48 U.S.C. 1421(h). In addition, the Inspections user fee does not currently cover the Service's operational costs on Guam. Appropriated funds are used to make up the difference. Therefore, there are no surplus funds from the Inspections user fee account that can be used to finance the enforcement efforts advocated by the commenters.

The Service is aware of the difficulties in enforcing the proposed rule in an ad hoc fashion. In order to address the concerns of the commenters and to be in compliance with our own obligation to enforce the nondiscriminatory limitations on habitual residence provided for by the Compacts and Congress, the Service intends to work with the Government of Guam and the United States Department of the Interior in order to establish methods to fairly enforce the nondiscriminatory limitations on habitual residence. (The term “nondiscriminatory” is discussed in the supplementary information portion of the proposed rule. Since the Service has made no changes in how the term is used, there is no need here for further discussion.)

The Service will enforce the existing requirement that all nonimmigrants, including FAS citizens entering a United States territory, complete Service Form I-94, Arrival-Departure Record, and turn it in, as required, upon departure. See 8 CFR 235.1(f) The Service may extract information from the I-94 for possible enforcement purposes and may share this information with the Government of Guam on an as-needed basis.

The final rule, therefore, establishes the rebuttable presumption that an FAS citizen is a habitual resident if the Service has reasons to believe that the FAS citizen was admitted to a United States territory more than a year ago but failed to turn in his or her I-94 upon departure, or failed to apply for a replacement arrival-departure record. Having the correct information, as gleaned from the I-94, on a particular FAS citizen's arrival and departure is important. Without such information the Service will now know how much time the FAS citizen has previously spent within the territory, and therefore may not know whether or not the FAS citizen is a habitual resident.

This presumption approach the Service intends to use is similar to the concept employed in a parking lot in order to determine the amount a driver must pay for parking. Upon entering the lot, the driver gets a ticket and then turns it in upon leaving to determine how much to pay. If the driver loses his or her ticket, the parking lot charges the driver for the maximum amount of time, since the parking lot attendant is able to know only when the driver is leaving. The burden is always on the driver to prove the time of entry into the parking lot. In this example, the driver's entry is proven via the parking lot ticket.

The Service will apply the same concept to the situation at hand. If the Service only knows when the FAS citizen was previously admitted, the burden is on the FAS citizen to show when he or she departed. The form itself requires that it be surrendered upon departure. The presumption can be rebutted by evidence that the FAS citizen was not in the territory for a total of at least 365 days and has not established a continuing or lasting residence. If the FAS citizen can prove he or she made an entry elsewhere on a specific date, that will demonstrate that he or she was not in the territory between that date and the date of his or her next application for admission to the United States territory.

The Service notes that the definition of “habitual resident” has been modified in this context in order to conform more closely to the definition of “habitual residence” found in section 461 of the Compacts. In particular, the Service notes that for an FAS citizen to be considered a habitual resident, he or she must have a continuing or lasting residence in the United States territory after an admission, including physical presence for a cumulative total of at least 365 days. The fact that an FAS citizen may be a habitual resident does not necessarily render the FAS citizen inadmissible to the United States territory. For example, if the resident is self-supporting, he or she may not necessarily be inadmissible.

Finally, organization of the final rule is different from that of the proposed rule in order to comply with the plain-language requirements currently used by Executive Branch agencies in drafting regulations.

Regulatory Flexibility Act

The Commissioner of the Immigration and Naturalization Service, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that the rule will not have a significant economic impact on a substantial number of small entities. This rule affects relatively small communities, primarily on Guam. Because the rule would require that the nonimmigrant be self-supporting in order to establish and maintain habitual residence in a territory or possession of the United States, the impact of the rule on the local economies should be positive.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

Executive Order 12866

This rule is not considered by the Department of Justice, Immigration and Naturalization Service to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, the Office of Management and Budget has waived its review process under section 6(a)(3)(A).

Executive Order 13132

The regulation proposed will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Summary Impact Statement.

Executive Order 12988 Civil Justice Reform

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

Accordingly, part 214 of chapter I of title 8 of the Code of Federal Regulations is amended as follows:PART 214—NONIMMIGRANT CLASSES1. The authority citation for part 214 is revised to read as follows:Authority:

8 U.S.C. 1101, 1103, 1182, 1184, 1186a, 1187, 1221, 1281, 1282; sec. 643, Pub. L. 104-208, 110 Stat. 3009-708; Section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau, 48 U.S.C. 1901, note, and 1931 note, respectively; 8 CFR part 2.

2. Section 214.7 is added to read as follows:§ 214.7 What is habitual residence in the territories and possessions of the United States and what are the consequences thereof?

(a) Definitions. As used in this section, the term:

(1) Compacts means the agreements of free association between the United States and the governments of the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau, approved by Public Law 99-239 with respect to the governments of the Republic of the Marshall Islands and the Federated States of Micronesia, and by Public Law 99-658, with respect to Palau.

(2) Freely associated states (FAS) means the following parts of the former Trust Territories of the Pacific Islands, namely, the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau.

(3) Territories and possessions of the United States means all territories and possessions of the United States to which the Act applies, including those commonwealths of the United States that are not States. It does not include American Samoa and the Commonwealth of the Northern Mariana Islands, as long as the Act does not apply to them.

(4)(i) Habitual resident means a citizen of the FAS who has been admitted to a territory or possession of the United States (other than American Samoa or the Commonwealth of the Northern Mariana Islands, as long as the Act is not applicable to them) pursuant to section 141(a) of the Compacts and who occupies in such territory or possession a habitual residence as that term is defined in section 461 of the Compacts, namely a place of general abode or a principal, actual dwelling place of a continuing or lasting nature. The term “habitual resident” does not apply to:

(A) A person who has established a continuing residence in a territory or possession of the United States, but whose cumulative physical presence in the United States amounts to less than 365 days; or

(B) A dependent of a resident representative described in section 152 of the Compacts; or

(C) A person who entered the United States for the purpose of full-time studies as long as such person maintains that status.

(ii) Since the term “habitual” resident requires that the person have entered the United States pursuant to section 141(a) of the Compacts, the term does not apply to FAS citizens whose presence in the territories or possessions is based on an authority other than section 141(a), such as:

(A) Members of the Armed Forces of the United States described in 8 CFR § 235.1(c);

(B) Persons lawfully admitted for permanent residence in the United States; or

(C) Persons having nonimmigrant status whose entry into the United States is based on provisions of the Compacts or the Act other than section 141(a) of the Compacts.

(5) Dependent means a citizen of the FAS, as defined in section 141(a) of the Compacts, who:

(i) Is a habitual resident;

(ii) Resides with a principal habitual resident;

(iii) Relies for financial support on that principal habitual resident; and

(iv) Is either the parent, spouse, or unmarried child under the age of 21 of the principal habitual resident or the parent or child of the spouse of the principal habitual resident.

(6) Principal habitual resident means a habitual resident with whom one or more dependents reside and on whom dependent(s) rely for financial support.

(7) Self-supporting means:

(i) Having a lawful occupation of a current and continuing nature that provides 40 hours of gainful employment each week. A part-time student attending an accredited college or institution of higher learning in a territory or possession of the United States receives for each college or graduate credit-hour of study a three-hour credit toward the 40-hour requirement; or

(ii) If the person cannot meet the 40-hour employment requirement, having lawfully derived funds that meet or exceed 100 percent of the official poverty guidelines for Hawaii for a family unit of the appropriate size as published annually by the Department of Health and Human Services.

(8) Receipt of unauthorized public benefits means the acceptance of public benefits by fraud or willful misrepresentation in violation of section 401 or 411 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, Public Law 104-193, 110 Stat. 2261, 2268, as amended by sections 5561 and 5565 of the Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 638. 639.

(b) Where do these rules regarding habitual residence apply? The rules in this section apply to habitual residents living in a territory or possession of the United States to which the Act applies. Those territories and possessions are at present Guam, the Commonwealth of Puerto Rico, and the American Virgin Islands. These rules do not apply to habitual residents living in American Samoa or the Commonwealth of the Northern Mariana Islands, as long as the Act does not extend to them. These rules are not applicable to habitual residents living in the fifty States or the District of Columbia.

(c) When is an arriving FAS citizen presumed to be a habitual resident? (1) An arriving FAS citizen will be subject to the rebuttable presumption that he or she is a habitual resident if the Service has reason to believe that the arriving FAS citizen was previously admitted to the territory or possession more than one year ago; and

(2) That the arriving FAS citizen either;

(i) Failed to turn in his or her Form I-94 when he or she previously departed from the United States; or

(ii) Failed to apply for a replacement Form I-94.

(d) What rights do habitual residents have? Habitual residents have the right to enter, reside, study, and work in the United States, its territories or possessions, in nonimmigrant status without regard to the requirements of sections 212(a)(5)(A) and 212(a)(7)(A) and (B) of the Act.

(e) What are the limitations on the rights of habitual residents? (1) A habitual resident who is not a dependent is subject to removal if he or she:

(i) Is not and has not been self-supporting for a period exceeding 60 consecutive days for reasons other than a lawful strike or other labor dispute involving work stoppage; or

(ii) Has received unauthorized public benefits by fraud or willful misrepresentation; or

(iii) Is subject to removal pursuant to section 237 of the Act, or any other provision of the Act.

(2) Any dependent is removable from a territory or possession of the United States if:

(i) The principal habitual resident who financially supports him or her and with whom he or she resides, becomes subject to removal unless the dependent establishes that he or she has become a dependent of another habitual resident or becomes self-supporting; or

(ii) The dependent, as an individual, receives unauthorized public benefits by fraud or willful misrepresentation; or

(iii) The dependent, as an individual, is subject to removal pursuant to section 237 of the Act, or any other provision of the Act.

This action amends FAA regulations relating to airspace designations to reflect the approval by the Director of the Federal Register of the incorporation by reference of FAA Order 7400.9H, Airspace Designations and Reporting Points. This action also explains the procedures the FAA will use to amend the listings of Class A, Class B, Class C, Class D, and Class E airspace areas and reporting points incorporated by reference.

DATES:

These regulations are effective September 16, 2000, through September 15, 2001. The incorporation by reference of FAA Order 7400.9H is approved by the Director of the Federal Register as of September 16, 2000, through September 15, 2001.

FAA Order 7400.9G, Airspace Designations and Reporting Points, dated September 1, 1999, and effective September 16, 1999, listed Class A, Class B, Class C, Class D, and Class E airspace areas and reporting points. Due to the length of these descriptions, the FAA requested approval from the Office of the Federal Register to incorporate the material by reference in the Federal Aviation Regulations § 71.1 (14 CFR 71.1). The Director of the Federal Register approved the incorporation by reference of FAA Order 7400.9G in § 71.1, effective September 16, 1999, through September 15, 2000. During the incorporation by reference period, the FAA processed all proposed changes of the airspace listings in FAA Order 7400.9G in full text as proposed rule documents in the Federal Register. Likewise, all amendments of these listings were published in full text as final rules in the Federal Register. This rule reflects the periodic integration of these final rule amendments into a revised edition of Airspace Designations and Reporting Points, Order 7400.9H. The Director of the Federal Register has approved the incorporation by reference of FAA Order 7400.9H in § 71.1, as of September 16, 2000, through September 15, 2001. This rule also explains the procedures the FAA will use to amend the airspace designations incorporated by reference in part 71. Sections 71.5, 71.31, 71.33, 71.41, 71.51, 71.61, 71.71, 71.79, and 71.901 are also updated to reflect the incorporation by reference of FAA Order 7400.9H.

The Rule

This action amends part 71 of the Federal Aviation Regulations (14 CFR part 71) to reflect the approval by the Director of the Federal Register of the incorporation by reference of FAA Order 7400.9H, effective September 16, 2000, through September 15, 2001. During the incorporation by reference period, the FAA will continue to process all proposed changes of the airspace listings in FAA Order 7400.9H in full text as proposed rule documents in the Federal Register. Likewise, all amendments of these listings will be published in full text as final rules in the Federal Register. The FAA will periodically integrate all final rule amendments into a revised edition of the Order, and submit the revised edition to the Director of the Federal Register for approval for incorporation by reference in § 71.1.

The FAA has determined that this action: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. This action neither places any new restrictions or requirements on the public, nor changes the dimensions or operating requirements of the airspace listings incorporated by reference in part 71. Consequently, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Because this action will continue to update the changes to the airspace designations, which are depicted on aeronautical charts, and to avoid any unnecessary pilot confusion, I find that good cause exists, under 5 U.S.C. 553(d), for making this amendment effective in less than 30 days.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

The complete listing for all Class A, Class B, Class C, Class D, and Class E airspace areas and for all reporting points can be found in FAA Order 7400.9H, Airspace Designations and Reporting Points, dated September 1, 2000. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The approval to incorporate by reference FAA Order 7400.9H is effective September 16, 2000, through September 15, 2001. During the incorporation by reference period, proposed changes to the listings of Class A, Class B, Class C, Class D, and Class E airspace areas and to reporting points will be published in full text as proposed rule documents in the Federal Register. Amendments to the listings of Class A, Class B, Class C, Class D, and Class E airspace areas and to reporting points will be published in full text as final rules in the Federal Register. Periodically, the final rule amendments will be integrated into a revised edition of the Order and submitted to the Director of the Federal Register for approval for incorporation by reference in this section. Copies of FAA Order 7400.9H may be obtained from the Airspace and Rules Division, ATA-400, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591, (202) 267-8783. Copies of FAA Order 7400.9H may be inspected in Docket No. 29334 at the Federal Aviation Administration, Office of the Chief Counsel, AGC-200, Room 915G, 800 Independence Avenue, SW., Washington, D.C., weekdays between 8:30 a.m. and 5:00 p.m., or at the Office of the Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC. This section is effective September 16, 2000, through September 15, 2001.

§ 71.5 [Amended] 3. Section 71.5 is amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”.§ 71.31 [Amended] 4. Section 71.31 is amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”. § 71.33 [Amended] 5. Paragraph (c) of § 71.33 is amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”.§ 71.41 [Amended] 6. Section 71.41 is amended by removing the words “FAA Order 7400.9G” each place they appear and adding, in their place, the words “FAA Order 7400.9H”.§ 71.51 [Amended] 7. Section 71.51 is amended by removing the words “FAA Order 7400.9G” each place they appear and adding, in their place, the words “FAA Order 7400.9H”.§ 71.61 [Amended] 8. Section 71.61 is amended by removing the words “FAA Order 7400.9G” each place they appear and adding, in their place, the words “FAA Order 7400.9H”.§ 71.71 [Amended] 9. Paragraphs (b), (c), (d), (e), and (f) of § 71.71 are amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”.§ 71.79 [Amended] 10. Section 71.79 is amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”.§ 71.901 [Amended] 11. Paragraph (a) of § 71.901 is amended by removing the words “FAA Order 7400.9G” and adding, in their place, the words “FAA Order 7400.9H”.Issued in Washington, DC, September 8, 2000. Reginald C. Matthews, Manager, Airspace and Rules Division. [FR Doc. 00-23673 Filed 9-18-00; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATIONFederal Aviation Administration14 CFR Part 71[Airspace Docket No. 00-ACE-13]Amendment to Class E Airspace; Fairfield, IAAGENCY:

Federal Aviation Administration, DOT.

ACTION:

Direct final rule; confirmation of effective date.

SUMMARY:

This document confirms the effective date of a direct final rule which revises Class E airspace at Fairfield, IA.

DATES:

The direct final rule published at 65 FR 40991 is effective on 0901 UTC, November 30, 2000.

The FAA published this direct final rule with a request for comments in the Federal Register on July 3, 2000 (65 FR 40991). The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on November 30, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The Modernization Act codified certain parts of the agency's current “Good Guidance Practices” (GGP's) and directed the agency to issue a regulation consistent with the act that specifies FDA's policies and procedures for the development, issuance, and use of guidance documents. The intended effect of this regulation is to make the agency's procedures for development, issuance, and use of guidance documents clear to the public.

Under section 405 of the Modernization Act (Public Law 105-115), statutory provisions on guidance documents were added to the Federal Food, Drug, and Cosmetic Act (the act) in section 701(h) (21 U.S.C. 371(h)). In the Federal Register of February 14, 2000 (65 FR 7321), we (FDA) proposed changes to our existing part 10 (21 CFR part 10) regulations to clarify our procedures for the development, issuance, and use of guidance documents. Interested parties were given until May 1, 2000, to comment on the proposal.

II. Description of the Final Rule A. Comments and Agency Response

We received 18 comments on the proposed rule, largely from trade organizations. The comments we received generally supported the policies and procedures described in the GGP's.

1. General Comment

(Comment 1) One comment recommended that we include in this preamble a list of generally accepted principles of a good guidance document. The comment nominated several principles for inclusion on the list.

We decline to develop a list of generally accepted principles of a “good” guidance document because we believe that the procedures described in § 10.115 reflect generally accepted principles for developing, issuing, and using guidance documents. For example, a good guidance document represents our current thinking on a matter and clearly states that it does not establish legally enforceable requirements. We expect each guidance document developed, issued, and used under the rule to have the characteristics of a good guidance document.

2. Definition of Guidance Documents

(Comment 2) One comment suggested that we include in the definition of guidance documents those documents that describe our current policies regarding labeling and promotion.

In our proposal, we defined guidance documents to include, among other kinds of documents, those that relate to the design, production, manufacturing, and testing of regulated products and those that relate to inspection or enforcement policies. We interpret our definition to include guidance documents about product labeling and promotion. We are amending the definition in § 10.115(b)(2) to clarify our intent to include such topics as subjects for guidance documents.

(Comment 3) Several comments discussed the annual publication of the comprehensive list of guidance documents and the guidance document agenda. Some suggested that we continue to publish these lists on a semiannual basis.

Some comments stated that yearly publication of the comprehensive list is acceptable, particularly given that we maintain a current list on the Internet.

One comment stated that annual publication of the guidance document agenda would be reasonable if we include the status of each item on the list and identify the highest priority guidance documents. Another comment recommended that the agenda be posted on the Internet.

We believe that we provide adequate notice of and access to all available guidance documents through two mechanisms. We annually publish a comprehensive list of guidance documents in the Federal Register and we maintain current (i.e., updated within 30 days of the issuance of a new or newly revised guidance document or the deletion of an obsolete guidance document) lists of guidance documents on the Internet.

We also believe that we provide adequate notice of the guidance document agenda through its annual publication in the Federal Register. We will not include the status of each document on the agenda. Each document listed on the agenda is being developed; further description of document status would not be practical because it would be too difficult to differentiate the stages of guidance document development. We also do not believe it would be feasible to prioritize the documents on the agenda. Often, resources allocated to the development of a particular document are diverted to creating guidance documents regarding other areas of greater public health need. As a result, our priorities may change throughout the year and priorities stated on the agenda would not remain accurate for an extended period of time. We try to maintain a current (i.e., updated at least semiannually) guidance document agenda on the Internet.

In efforts separate from this rulemaking, we are considering ways to enhance our lists of guidance documents maintained on the Internet. For example, we are trying to make the lists easier to navigate and search. These enhancements may allow you to more efficiently find the information you seek on the comprehensive list and the agenda.

(Comment 4) One comment suggested that we include a brief statement describing each document on the comprehensive list.

We understand that much of the value of the comprehensive list lies in its ability to convey the subject matter of each document on the list. To provide this information adequately, we plan to ensure that the titles or subtitles of documents convey the subject of the document more precisely. The comprehensive list could become too cumbersome and difficult to use if we added a description of the subject of each document. Therefore, we will not include a separate statement describing each document on the comprehensive list.

(Comment 5) A comment stated that the comprehensive list should identify guidance documents that have been revised or are currently being considered for revision.

Through the lists that we publish under the procedures previously described, we already make the information requested in the comment available to the public. On the comprehensive list, we include the date of the last revision of a guidance document. This enables you to identify those guidance documents that have been revised and the date of the revision. In our guidance document agenda, we list guidance documents that are under consideration for development or revision.

(Comment 6) In § 10.115(c), we define two levels of guidance documents, Level 1 and Level 2. The two levels of guidance documents are subject to different procedures for public participation before issuance. One comment suggested that we include the designation for each document as Level 1 or Level 2 in the prospective list of guidance documents.

We decline the suggestion to include the Level 1 or Level 2 designation for all documents on the guidance document agenda. Generally, at the time we issue the agenda, we do not know the full content of the proposed documents. Thus, a determination of whether a document meets the criteria for a Level 1 designation (§ 10.115(c)(1)) would be premature.

(Comment 7) One comment suggested that we make the guidance document agenda more user-friendly by separating guidance documents on cross-cutting issues from those that are technology-specific.

The purpose of the guidance document agenda is to notify you of guidance documents we are developing so you may comment on topics for new documents and possible revisions to existing documents. We believe the guidance agenda is currently organized to disseminate this information most effectively. The documents on the agenda are organized by the issuing center or office and generally are further grouped by topic categories. By separating guidance documents according to the issuing center or office, we enable those of you who have interest in a particular issue or type of product (e.g., food products) to focus on documents that are being developed in one of the centers or offices (e.g., the Center for Food Safety and Applied Nutrition). Guidance documents that are being developed in more than one center or office will appear on the agenda for each participating center or office. Grouping documents on the agenda by subject category (e.g., electronic submissions) provides you greater ability to focus on specific areas of interest. After the effective date of the rule, we will group all guidance documents on the agenda by subject category. This format is consistent with the format of the comprehensive list of guidance documents. We believe that the format suggested in the comment could make the agenda difficult to use because you would not be able to concentrate effectively on a particular topic of interest.

4. Public Input

(Comment 8) One comment suggested that we implement procedures to give you the opportunity to comment on designation of a document as a Level 1 or Level 2 guidance document before the decision is made.

We decline to adopt this suggestion. It is in the best interest of promoting and preserving the public health that we be able to develop guidance documents in a timely and efficient manner. If we solicited comment on the level designation for each guidance document, we would create a procedural hurdle that could significantly slow the guidance development process. This delay in the development of guidance documents would not serve us or you.

We determine whether a document is Level 1 or Level 2 based on the criteria described in § 10.115(c). If you disagree with the designation of a document (e.g., if you believe that a guidance issued as a Level 2 should have been issued as a Level 1), you may send us an explanation of your reasons for disagreeing with our determination when you comment on the guidance document. If, after issuance, you still have a disagreement, you can appeal our designation using the dispute resolution process.

(Comment 9) One comment suggested that we announce the development and issuance of Level 2 documents in the Federal Register. Another comment recommended that we receive comments on Level 2 guidance documents before we issue them as final guidance.

We decline to amend our procedures for announcing and receiving comment on Level 2 guidance documents. When we issue Level 2 documents, they are immediately posted on the Internet. Also, their issuance is announced in the comprehensive list of guidance documents that is published annually in the Federal Register and maintained on the Internet.

Under section 701(h)(1)(D) of the act, we must solicit public comments “upon implementation” of guidance documents that describe existing practices or minor changes in agency policy. We believe the provisions of § 10.115(g)(4) are consistent with the act and describe adequate provisions for developing and issuing Level 2 guidance documents.

(Comment 10) Under § 10.115(g)(1)(v), we may issue a second draft of a guidance document and solicit comment on the document after providing an opportunity for comment on the first draft. One comment stated that two situations usually merit this procedure: When the first draft guidance on a medical or scientific topic is highly controversial and when the first draft guidance is in conflict with other widely recognized sources of scholarly guidance (e.g., International Conference on Harmonization guidance, pharmacopeial standards).

We agree that it may be appropriate for us to issue a second draft of a guidance document in the two situations described in the comment. In addition, it may also be appropriate for us to issue a second draft guidance in other circumstances. For example, if we revise a document for clarification, we may want to issue a second draft guidance document to receive comment on whether our revisions made the document easier to understand.

(Comment 11) One comment suggested that we allow the public to request the deletion of guidance documents that are no longer useful.

Under § 10.115(f), you can suggest that a document on the comprehensive list of guidance documents or on the guidance document agenda be revised or withdrawn if you find that the document is no longer relevant or accurate. We amended the final rule to explicitly state that you can suggest that a guidance be withdrawn (§ 10.115(f)(4)).

(Comment 12) Many comments urged us to include a provision in the regulation requiring us to provide written responses to public comments or suggestions for revising guidance documents. One comment stated that we should respond to each suggestion for a revision to an existing guidance document within 90 days. Other comments stated that we should explain to the public why we changed, or why we did not change, a guidance document between the draft and final stages. Some comments recommended that we provide general responses to comments grouped by topic. Others suggested that we be required to issue a written response when certain criteria are met (e.g., when a majority of the comments on a guidance document concern the same issue).

We believe that it is in the public interest to have an efficient process for developing guidance documents. The guidance document development process would be hampered if we were required to respond to each comment. When comments received are very significant or cause us to revise a guidance, we often discuss those comments in the notice of availability (NOA) for the final guidance or in the final guidance document. We intend to continue this practice. However, making a firm commitment to provide a written response to all comments when issuing a final guidance would unnecessarily delay the issuance of the document.

(Comment 13) Two comments suggested that we be required to respond to your proposals for draft guidance documents.

We agree with this comment. When you have taken the time to develop a guidance document and submit it to us for review, you should receive, at a minimum, an acknowledgment of receipt of the document. Therefore, we are now accepting guidance document submissions at the Dockets Management Branch. If you submit a document to us, you should designate it as a “Guidance Document Submission,” include the name of the center or office with oversight over the subject matter covered by the guidance document, and submit the document to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The Dockets Management Branch will ensure that the document is assigned a public docket number and it is sent to the appropriate office or center. All proposed guidance documents will be available through the public docket. We will send you a written acknowledgment that we have received your document, and to the extent feasible, we also will inform you of our actions regarding the document you have submitted. These changes to the final rule are included in revised § 10.115(f)(3).

(Comment 14) We received many comments on early collaboration and meetings to discuss guidance documents as they are being developed. Generally, the comments were very supportive of our efforts to facilitate early interaction with you. Some comments suggested that we issue a clear policy about the procedures for collaboration and early meetings. One suggested that we provide a means for industry to recommend a particular collaborative approach for a guidance document under development. Another comment recommended that we provide opportunities for you to engage in “real time dialogues” with us before we begin to write a draft or final guidance. The comment noted a number of avenues for this type of collaboration, including joint task forces, public and private meetings, advisory committee meetings, and e-mail correspondence. Other comments stated that certain agency components had refused to meet about a guidance document before that document was issued in draft. One comment specifically requested that we use more mandatory language regarding preproposal collaboration with you.

We agree that early collaboration (i.e., input from you in the early stage of developing the approach we will take in a new or revised guidance document) can be a very valuable tool in developing regulatory guidance. We have created several mechanisms to encourage early input, including the following:

• We provide an opportunity to suggest new or revised guidance.

• We publish an agenda of the guidance documents that we are working on and request your comments on the agenda.

• We notify you when we issue draft guidance documents and request your comments on the drafts.

• We may hold meetings or workshops even before we develop a draft document.

We encourage your involvement in our development of guidance documents. Often, we develop guidance documents based on your suggestions. We solicit your comments on draft guidance documents because our views are not yet finalized and we want your input on the contents of the final guidance.

We understand that you would like to meet with us more regarding the development of guidance documents. Our policies on meeting with the public on guidance development are evolving. In efforts separate from this rulemaking, we are exploring ways to increase this interaction within the confines of applicable statutes and regulations, and are considering our need to provide all interested parties access to the process, our interest in issuing documents in a timely manner, and our resource constraints. We welcome your suggestions in this area.

(Comment 15) One comment proposed establishing a mechanism in § 10.115(g) whereby companies can fund a market research initiative that would permit us, through questionnaires, focus groups, and other techniques, to obtain input on proposed policies directly from patients, doctors, and other stakeholders.

We welcome input from patients, doctors, and other stakeholders. We believe that the procedures described in § 10.115, especially our increased use of the Internet to disseminate information, provide adequate avenues for patient, doctor, and stakeholder involvement in the development of our policies. We decline at this time to establish a funded market research initiative because administering such a program would divert personnel resources from other public health priorities.

(Comment 16) One comment suggested that we consider interactive techniques, such as town hall meetings, that may encourage industry input on setting priorities for the development of guidance documents listed on the agenda.

We welcome industry input on prioritizing our development of guidance documents. We believe that the procedures described in the GGP's on the guidance document agenda, especially our increased use of the Internet to disseminate the agenda and our request for comments on the agenda, provide adequate avenues for industry and others to assist us in prioritizing guidance documents. Furthermore, the agenda is only one of several mechanisms we use to solicit input on prioritizing the guidance documents we are developing. For example, we may participate in public meetings and public hearings and may raise guidance document issues at advisory committee meetings. At this time, we decline to change the GGP's in the manner suggested but will continue to consider avenues for encouraging input at all stages of guidance development.

(Comment 17) One comment suggested that any proposed guidance documents submitted to advisory committees be made public in a manner that provides sufficient time for review before the meeting.

We agree that proposed guidance documents submitted to advisory committees should be made public as soon as practicable to allow for a review of those materials. We are working to ensure that this information is made available in a timely manner.

5. Legal Effect of Guidance Documents

(Comment 18) We received several comments on the legal effect of guidance documents. A number of comments referred to the statement in the proposed regulation that we are willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations (§ 10.115(c)(3)). The comments stated that if a guidance document is not binding, the discussion of alternative approaches should not be required.

The comments misinterpreted the intent of the statement in § 10.115(c)(3). If you take an alternative approach, you are not required to discuss that approach with us. Instead, we are offering our assistance to make sure that any alternative approach you take meets the appropriate statutory or regulatory requirements. Discussing alternative approaches may help you understand our interpretation of the applicable statutes and regulations and may further our understanding of the merits of your approach.

(Comment 19) Two comments suggested that compliance with a guidance document should provide a company with a safe harbor from FDA enforcement action. The comments recommended that we change the regulation to require us to amend, or at least publish a proposal to amend, a guidance document before initiating an enforcement action against a company that acted in accordance with a guidance. The comments also noted that if we do not provide a safe harbor from enforcement, at a minimum, a company's action in accordance with a guidance document should be evidence of the company's intent to comply with our regulations.

Section 701(h)(1)(B) of the act provides that guidance documents “shall not be binding on the Secretary.” Creating a “safe harbor” in a guidance document that would preclude us from taking action would impermissibly bind us. In issuing enforcement-related guidance documents, we express our current thinking regarding regulatory matters and believe this provides useful information. However, you always remain independently responsible for complying with applicable statutes and regulations. Whether you have complied with the law is determined from the facts of each case.

(Comment 20) We received two comments suggesting that we clarify to our staff that FDA may not cite failure to follow a guidance document in any observation on Form FDA 483 (List of Inspectional Observations).

We agree with this comment. Guidance documents are not binding. An enforcement action may be taken only when we find a violation of statutory or regulatory requirements. If a guidance document contains a reference to a regulatory or statutory requirement, then enforcement action may be taken if the regulation or statutory requirement is violated. Of course, enforcement action may be taken if a requirement in a regulation or statute is violated whether or not there is a reference to the requirements in any guidance document. We discuss this issue in the GGP training we provide employees under § 10.115(l)(1).

(Comment 21) We received one comment on how we should interpret a draft guidance document during the time that it is out for comment, before the document has been finalized. The comment suggested that we maintain three categories of guidance documents: Draft, approvable, and approved.

We believe the provisions of § 10.115(g) sufficiently describe both the process for issuing draft Level 1 guidance documents for comment and the process of implementing Level 1 guidance documents without comment when prior public participation is not feasible or appropriate. We do not believe that adding more categories will improve the process; instead, it could confuse the users of the documents. Early in the process of developing the GGP's, comments strongly urged the agency to streamline and simplify the nomenclature for guidance documents. We have done so. If you are concerned about FDA's thinking on an issue that is reflected only in a draft guidance, you should contact the appropriate office within FDA to discuss the issue.

While a draft Level 1 guidance document is out for comment, you may be concerned that the guidance will change based on comments received. Because a guidance document represents the agency's current thinking on a subject but it is not ever binding on FDA or outside parties, you should not rely on any guidance document, draft or final. If you have questions about compliance with statutory or regulatory requirements, you can discuss those issues with an FDA employee.

6. Standard Elements

(Comment 22) We received two comments suggesting that the designation as Level 1 or Level 2 be a standard element of each guidance document.

We believe that the comment misinterpreted the significance of the Level 1 or Level 2 designation. The designation of a guidance as Level 1 or Level 2 is only relevant when a guidance document or revision to a guidance document is being developed. The designation is used to indicate whether the proposed document or revision is significant enough to warrant public comment before implementation. If the Level 1 or Level 2 determination remains with the document as a standard element, it may be confusing. For example, if we make a very minor revision to a guidance document that contains highly significant issues, this revision would warrant a Level 2 determination for the purposes of receiving comments. Affected parties should not assume that the document contains issues that are less significant because of the Level 2 designation, but rather that the change being made is not significant.

(Comment 23) One comment suggested that we require as an element in each guidance document a statement that explains why the document is needed.

Guidance documents should be issued only when a need for guidance exists. In each document, we generally include a background section that states the reason for its issuance. We will continue to do this in the future. However, although we acknowledge the utility of stating the need for each guidance, we do not believe the statement should be required. The advice we provide in a guidance document represents our current thinking, regardless of whether we adequately explain the need for the guidance. Therefore, we decline to make this information a required element in our guidance documents.

(Comment 24) One comment suggested that statements of nonbinding effect be prominently displayed on all guidance documents.

We agree with the comment. It is critical that all parties understand that guidance documents do not bind us or you. We are amending the regulation at § 10.115(i)(1)(iv) to require that a statement of the guidance document's nonbinding effect be displayed on prominently each document. In the future, this statement will be placed immediately below the title of the guidance document on the first page of text and it will be in prominent (e.g., bold or italic) print.

7. Our Procedures

(Comment 25) In the proposed rule, we stated that we would not seek public input prior to implementing a Level 1 guidance document if we determine that prior public participation is not feasible or appropriate (proposed § 10.115(g)(2)). Several comments discussed this exception to the prior public participation requirement. Two comments stated that we should use the exception only in rare and extraordinary circumstances. Other comments suggested that we only use this exception in cases where there is a real, demonstrated public health emergency, not just a theoretical emergency. Another comment stated that when we use these procedures, we should provide a statement of our reasons for not soliciting prior public participation.

Under section 701(h)(1)(C) of the act, we must ensure public participation prior to the implementation of guidance documents unless we determine that such prior public participation is not feasible or appropriate. As discussed in the preamble to the proposed rule, § 10.115(g)(2) reflects the standard stated in the statute (65 FR 7321 at 7324). We anticipate that this exception will generally be used when: (1) There are public health reasons for the immediate implementation of the guidance document; (2) there is a statutory requirement, executive order, or court order that requires immediate implementation; or (3) the guidance document presents a less burdensome policy that is consistent with public health. We agree that we should explain why a document is being issued without prior public participation when we issue the document. Generally, this explanation is included in the NOA for the guidance document. We will continue to follow this procedure in the future.

(Comment 26) One comment suggested that we adopt a 30-day grace period for Level 1 guidance documents issued without prior public participation.

A grace period would not be needed for a guidance document because guidance is not binding on us or you. We do not enforce guidance documents; we enforce applicable statutory and regulatory requirements.

We are committed to ensuring that you have the opportunity to participate in guidance document development as much as possible. Therefore, we will issue a Level 1 guidance document without prior public participation only if it is not feasible or appropriate to solicit your comments (e.g., a public health emergency or a court order requires the issuance of the guidance and we need to make the document available to the public as quickly as possible). A delay in implementation would not be appropriate in such circumstances.

(Comment 27) One comment noted that there are times when a Level 2 guidance document may become controversial and suggested that we adopt procedures whereby a Level 2 document could be withdrawn, redesignated as a Level 1 document, and reissued in draft for public comment.

We believe that the GGP's implicitly provide us with the ability to act as the comment describes. If our initial determination to issue a guidance document or amended guidance document using Level 2 procedures proves to be an incorrect decision because the document is highly controversial when issued, we may withdraw the guidance document and reissue it as a draft guidance document following Level 1 procedures (i.e., publish an NOA in the Federal Register for the draft guidance document and solicit comments on the draft). We do not believe the rule should be amended to reflect these procedures.

(Comment 28) Two comments suggested that we use the Internet to the greatest extent possible to disseminate guidance documents. Several comments specifically requested that we allow submission of comments on guidance documents through e-mail.

We use the Internet as our primary means of disseminating guidance documents. In most cases, newly issued or revised guidance documents are available on the Internet at the same time they are available through other means (e.g., through the Dockets Management Branch). We are developing new ways to use Internet technology to enhance our ability to disseminate information to the public. In particular, we are developing a system for providing access to all documents on the Internet and facilitating e-mail submission of comments on guidance documents.

(Comment 29) One comment suggested that we publish a new guidance document within 30 days of changing our current thinking on a given subject. This comment also urged us to amend the regulations to clarify that the information in a guidance document may be relied on to be currently acceptable to FDA.

We agree that guidance documents should reflect our current thinking on a given subject. We try to ensure that our documents are current. However, we allocate our limited resources to the areas of greatest public health need. Although GGP's help to ensure a greater level of public participation in guidance development, following these procedures often means that it takes longer to issue guidance documents. Therefore, we will not commit ourselves to issuing guidance documents within a specific timeframe. We need flexibility to allocate our resources as we see fit, for example, to an area that presents more significant public health issues.

In response to the second part of the comment, § 10.115(d)(3) of the final rule clearly states that guidance documents represent the agency's current thinking on the subject of the document, and that FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.

(Comment 30) One comment stated that if we depart from a guidance document on multiple occasions, we should consider revising the document. A similar comment noted that when a change in policy allows deviation from a guidance document, we should amend the document to indicate the existence of limited exceptions.

As discussed previously, guidance documents should represent our current thinking on the matters discussed in the documents. Our consistent deviation from a guidance document might suggest that we should revise it. Furthermore, we should amend guidance documents to clarify any changes in our interpretation of a guidance document. As resources allow, we will continue to update and revise guidance documents to reflect our current thinking.

(Comment 31) One comment suggested that we provide written justification for deviating from a guidance document.

As discussed in the preamble to the proposed rule (65 FR 7321 at 7327), we agree that our employees should not deviate from guidance without appropriate justification and supervisory concurrence. However, because guidance documents are not legally binding, we do not believe that we should provide written notice stating the reasons for such deviations. If we are asked to explain why we are deviating from a guidance document, we will do so.

(Comment 32) One comment suggested that we consolidate guidance documents addressing identical topics, those covering one topic that applies to several premarketing application types, and those containing identical premarketing application elements for similar product lines. This comment also noted that some currently available guidance documents are obsolete, redundant, or no longer appropriate.

We consolidate similar guidance documents when feasible and appropriate. Our primary concern is to issue documents that represent our current thinking on a particular matter. On balance, the benefit of having consolidated guidance documents is often outweighed by the burden of reissuing the documents. Furthermore, consolidated documents may be too cumbersome to be user-friendly.

We agree that documents that are obsolete, redundant, or no longer appropriate should be revised or withdrawn so they do not create confusion. During the past few years, we have tried to eliminate or revise documents when appropriate, given our resource constraints. We will continue this practice. Section 10.115(f) provides you with an opportunity to suggest documents that should be eliminated or revised.

(Comment 33) One comment noted that we should not use guidance documents as a replacement for notice-and-comment rulemaking.

We agree with this comment and believe that in certain circumstances regulations should be issued, while in other circumstances issuance of a guidance document is more appropriate. We carefully consider whether a document that contains binding requirements should be issued. This decision ultimately determines whether it is more appropriate for us to issue regulations or guidance on a given subject.

(Comment 34) We received several comments on our dispute resolution process. One comment suggested that we establish a systematic review process for external auditors to examine the decisions of our staff and to determine whether the application of a guidance document was appropriate. One comment encouraged us to develop an appeals process to address complaints about our development and use of guidance documents, stating that this appeals process is required by the Modernization Act. Other comments suggested that we describe the normal appeals process for disputes about the content of a guidance document in this final rule.

We appreciate the importance of providing effective mechanisms for dispute resolution and recognize that guidance documents need to be developed, issued, and used in a manner that is consistent with GGP's. However, we believe that an evaluation of our current dispute resolution system by an external auditor is unnecessary. We are required under section 405 of the Modernization Act to ensure that an effective appeals mechanism is in place to address complaints about our development and use of guidance documents. We believe that we have such a mechanism in place.

If you believe that an FDA staff member did not follow the GGP's, including any situation where you believe a staff member treated a guidance document as binding, under § 10.115(o) you can raise the issue with that staff member's supervisor. If the issue cannot be resolved, you can continue raising it through the chain of command. These procedures complement our dispute resolution regulation in § 10.75 (internal review of decisions). You can also use the procedures in § 10.75 to appeal a decision on the GGP's. We are amending the final rule to provide another means for raising an issue about our implementation of the GGP's. Under amended § 10.115(o), you can contact the ombudsman of the center or office with which you have a dispute and seek the ombudsman's assistance in resolving the issue. Finally, if you feel that you are not making progress or if you are unable to resolve the issue at the center or office level, you can request that our Chief Mediator and Ombudsman become involved. Each center and office has made or will make available its own guidance documents on specific procedures for resolving disputes.

You may also petition us under § 10.30 (citizen petitions) and request that we formally resolve your issue.

(Comment 35) One comment suggested that we explicitly state that guidance documents apply to all parties who work in the area addressed by the document. The comment stated that historically, we have not applied guidance documents uniformly to work undertaken by different individuals.

In each document, we generally include an introductory section that states the intended audience of the guidance document (e.g., applicants, reviewers). The guidance document applies to all members of the intended audience. If you believe that an FDA staff member is not interpreting the document appropriately, you can follow the dispute resolution procedures described previously and in § 10.115(o).

(Comment 36) One comment suggested that we post the names and titles of the supervisors for each center/office on our Internet home page (www.fda.gov).

We agree that information about the individuals to contact regarding the resolution of a dispute should be readily available. This information is currently on the Internet for all of the centers and offices. You can find the organizational charts at the following Internet addresses:

(Comment 37) In § 10.115(l)(2), we state that our centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed. One comment suggested that we consider using a center ombudsman (e.g., the new ombudsman in the Center for Devices and Radiological Health) to perform this monitoring function.

We agree that it is important to ensure that guidance documents are developed and issued consistently by all centers and offices. Therefore, each center and office will designate one or more persons to monitor the development and issuance of its guidance documents. The center or office can designate the ombudsman and/or other individuals to perform this function.

As discussed previously, under § 10.115(o) you may seek the assistance of a center or office ombudsman or the Office of the Chief Mediator and Ombudsman if you believe that someone at FDA is not following the GGP's.

(Comment 38) One comment said that if we are serious about ensuring that our employees do not develop policy through speeches and other informal mechanisms, we should update and enforce internal written procedures on this subject. Another comment suggested that we state that our employees may not make statements at advisory committee meetings as a means to communicate new regulatory expectations.

We stated in the proposed regulation at § 10.115(e) that we may not use documents and other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to the public for the first time. We are maintaining this language in the final rule. Part of our GGP training for employees includes the understanding that policy is not to be communicated initially to a broad audience through speeches. Statements at advisory committee meetings often depend on the context of the statement. If, for example, a marketing application under consideration raises a novel issue, it may be appropriate for an FDA employee to comment on that issue as it relates to a specific application during a public advisory committee meeting. If there are questions raised by an advisory committee member that are not about a specific application, an individual employee can express a view, but this would not reflect official agency policy.

(Comment 39) One comment suggested that we examine our processes for training, evaluation, and related internal guidance to ensure that our directives to staff reinforce the appropriate use of guidance documents.

Section 701(h)(1)(B) of the act requires us to provide training for employees on how to develop and use guidance documents. We train employees about guidance documents in new employee orientation and/or as part of continuing employee education and training programs. Internal procedural documents are examined before they are issued to ensure that they are consistent with our GGP policies.

(Comment 40) Several comments recommended that there be better internal coordination among centers in the development, issuance, and use of guidance documents. In particular, one comment suggested that FDA ensure closer communication among centers, clarify the role of each center in oversight, and communicate clearly the enforcing center's expectation of a firm's responsibility for following a guidance document.

One comment referred to the “enforcing” center. We note that guidance is not enforceable. It is not binding on you or us.

In section 123 of the Modernization Act, Congress directed us to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the act (21 U.S.C. 355(b)(1)). We have made a concerted effort to minimize those differences and otherwise streamline the regulation of products that may involve dual jurisdiction of our centers. As part of this effort, we have issued numerous joint guidance documents.

We also have several checks within the guidance document development process that help to ensure that there is communication among centers on multicenter topics. For example, Level 1 guidance documents that describe new legal interpretations or significant changes in our policy are reviewed by the Office of the Chief Counsel and the Office of Policy before issuance. These offices are aware of cross-cutting issues and can ensure appropriate coordination.

(Comment 41) A comment suggested that we define the minimum levels of approval authority for sign-off on guidance documents.

We understand that having the appropriate level of clearance on guidance documents is important for purposes of quality control and to achieve the greatest level of consistency across the agency. However, we believe that we should maintain flexibility by providing discretion to the various centers and offices to determine their appropriate levels of clearance. Therefore, we decline the suggestion to mandate minimum levels of approval authority for guidance documents.

(Comment 42) One comment suggested that we clarify the status of advisory opinions and determine whether they are guidance documents.

We issue advisory opinions under § 10.85. We anticipate modifying § 10.85 and explaining the effect of § 10.115 on previously issued advisory opinions in a separate rulemaking effort. As such, the comment is outside the scope of this rulemaking.

(Comment 43) Two comments suggested that we clarify the status of guidelines. One recommended that we designate them as Level 1 guidance.

Our ability to issue guidelines was described in § 10.90(b). In the conforming amendments to the proposed rule, we proposed to delete all references to guidelines in § 10.90(b) and replace the provision with the statement that guidance documents will be developed, issued, and used according to the requirements at § 10.115. On further consideration, we have decided not to include a provision on guidance documents in § 10.90(b) because it is not necessary to state that guidance documents will be regulated under § 10.115. Therefore, we are removing and reserving § 10.90(b).

As described in the preamble to the proposed rule, all guidelines are now treated as guidance documents (65 FR 7321 at 7326). Because we no longer issue guidelines, we need not determine whether they would warrant a Level 1 or Level 2 determination. If any documents previously issued as guidelines are amended, we will follow the same procedures used for amending guidance documents (i.e., we will determine whether modifying the document meets the criteria for a Level 1 or Level 2 change).

(Comment 44) One comment asked whether we ensure that all broadly disseminated letters are posted on the Internet and whether we have procedures in place for quality control of this process.

We currently post all broadly disseminated letters on the Internet, including “Dear Doctor” letters, and letters that are broadly circulated but do not provide the agency's current thinking on a regulatory issue. All broadly disseminated letters that fall under the definition of guidance documents are issued under the procedures described in this rule. Each center and office has personnel who determine whether a broadly disseminated letter meets the criteria for a guidance document and should be issued as such.

(Comment 45) One comment asked whether we post on the Internet letters containing information about public health alerts.

In § 10.115(b)(3), we clarify that guidance documents do not include general information documents provided to consumers or health professionals. Public health alerts fall within this category of documents. While public health alerts are not guidance documents, and the comment is beyond the scope of this rulemaking, we do post such information on the Internet, as appropriate.

(Comment 46) One comment questioned whether we have a mechanism in place for receiving and evaluating suggestions for novel or more efficient procedures. The same comment suggested that we create a data base that contains all correspondence issued to a company. The comment also requested that we post on the Internet all of our speeches and the preamble to the September 29, 1978, current good manufacturing practices (CGMP's) regulation.

These comments are beyond the scope of this rulemaking.

B. Guidance Documents Resulting From International Negotiations

In addition to amending the final rule as described previously in response to comments, we are making one revision that will improve our ability to participate in international negotiations on guidance documents. As described in § 10.115(i)(1) and (i)(2), a guidance document must: (1) Include the term “guidance,” (2) identify the center(s) or office(s) issuing the document, (3) identify the activity to which and the people to whom the document applies, (4) include a statement of the document's nonbinding effect, (5) include the date of issuance, (6) note if it is a revision to a previously issued guidance, and (7) contain the word “draft” if the document is a draft guidance. Furthermore, guidance documents must not include mandatory language such as “must” or “required” unless we use those words to describe a statutory or regulatory requirement.

In accordance with our mission, we actively participate in international efforts to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements (section 903(b)(3) of the act 21 U.S.C. 393(b)(3)). Through these efforts, we frequently negotiate guidance documents with representatives of other countries. For example, our participation in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has allowed us to work with representatives of regulatory authorities from Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to develop numerous guidance documents on the regulation of human drug and biological products.

When draft documents are negotiated with representatives of other countries, we seek public comment on the resulting documents. We believe it is important to publish draft documents for comment at the same time as other countries so we may review the public comments and resume negotiations in a timely manner. However, other countries do not follow our GGP's; therefore internationally negotiated draft documents often do not comply with all of the provisions of § 10.115(i)(1) and (i)(2). For example, documents negotiated through ICH do not include the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as issuing offices. Differences in language and use of certain terms often result in wording that implies the draft documents establish mandatory requirements. Therefore, to facilitate the development and issuance of draft documents resulting from international negotiations, we have modified the final rule to state that when issuing “draft” guidances that are the product of international negotiations, we need not apply the provisions of § 10.115(i)(1) and (i)(2). However, we recognize and the final rule provides that final guidances that are the product of international negotiations must comply with all of the provisions of § 10.115(i). We anticipate that this amendment will provide many advantages, including our ability to: (1) Provide more time for public comment on draft guidance documents that are the result of international negotiations, (2) receive more public comments on these draft documents, (3) negotiate based on issues raised in public comments more effectively, and (4) resume international negotiations in a timely manner.

III. Conforming Amendments

We refer to guidelines issued under former § 10.90(b) throughout our regulations. Because we are revising our administrative regulations by deleting guidelines and adding guidance documents issued under § 10.115, we are making conforming amendments to 21 CFR parts 7, 10, 14, 19, 25, 101, 107, 110, 114, 170, 310, 312, 314, 316, 500, 514, 601, 803, 814, and 860 to reflect our changes. We are also adding § 601.29, Guidance documents, to the biologics regulations, to be consistent with §§ 312.145, 314.445, and 814.20. These conforming amendments will ensure the accuracy and consistency of the regulations.

IV. Environmental Impact

The agency has determined under 21 CFR 25.30 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required statement would be required.

V. Analysis of Impact

We have examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule may have a significant economic impact on a substantial number of small entities, an agency must consider alternatives that would minimize the economic impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written assessment of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).

We believe that this final rule is consistent with the regulatory philosophy and principles identified in Executive Order 12866 and in these two statutes. This rule does not impose any mandates on State, local, or tribal governments. The rule will not be significant as defined by the Executive Order and will not require further analysis under the Regulatory Flexibility Act. The Unfunded Mandates Reform Act does not require us to prepare a statement of costs and benefits for the rule because the rule in any 1-year expenditure would not exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $110 million.

VI. Paperwork Reduction Act of 1995

This regulation would impose no additional reporting or recordkeeping requirements. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

§ 7.1 [Amended]2. In § 7.1, remove the word “guidelines” and add in its place the word “guidance”.Subpart C [Amended] 3. In the heading for subpart C, consisting of §§ 7.40 through 7.59, remove the word “guidelines” and add in its place the word “guidance”.§ 7.40 [Amended] 4. In 7.40(a), remove the word “guidelines” and add in its place the word “guidance”.PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES 5. The authority citation for 21 CFR part 10 continues to read as follows: Authority:

(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.

(b) What is a guidance document?

(1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.

(2) Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.

(i) Set forth initial interpretations of statutory or regulatory requirements;

(ii) Set forth changes in interpretation or policy that are of more than a minor nature;

(iii) Include complex scientific issues; or

(iv) Cover highly controversial issues.

(2) “Level 2 guidance documents” are guidance documents that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.

(3) “You” refers to all affected parties outside of FDA.

(d) Are you or FDA required to follow a guidance document?

(1) No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.

(2) You may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations.

(3) Although guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.

(e) Can FDA use means other than a guidance document to communicate new agency policy or a new regulatory approach to a broad public audience? The agency may not use documents or other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to a broad public audience for the first time. These GGP's must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.

(f) How can you participate in the development and issuance of guidance documents?

(1) You can provide input on guidance documents that FDA is developing under the procedures described in paragraph (g) of this section.

(2) You can suggest areas for guidance document development. Your suggestions should address why a guidance document is necessary.

(3) You can submit drafts of proposed guidance documents for FDA to consider. When you do so, you should mark the document “Guidance Document Submission” and submit it to Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(4) You can, at any time, suggest that FDA revise or withdraw an already existing guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.

(5) Once a year, FDA will publish, both in the Federal Register and on the Internet, a list of possible topics for future guidance document development or revision during the next year. You can comment on this list (e.g., by suggesting alternatives or making recommendations on the topics that FDA is considering).

(6) To participate in the development and issuance of guidance documents through one of the mechanisms described in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should contact the center or office that is responsible for the regulatory activity covered by the guidance document.

(7) If FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the procedures described in paragraph (g) of this section.

(g) What are FDA's procedures for developing and issuing guidance documents?

(1) FDA's procedures for the development and issuance of Level 1 guidance documents are as follows:

(i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.

(A) Publish a notice in the Federal Register announcing that the draft guidance document is available;

(B) Post the draft guidance document on the Internet and make it available in hard copy; and

(C) Invite your comment on the draft guidance document. Paragraph (h) of this section tells you how to submit your comments.

(iii) After FDA prepares a draft of a Level 1 guidance document, FDA also can:

(A) Hold public meetings or workshops; or

(B) Present the draft guidance document to an advisory committee for review.

(iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will:

(A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate;

(B) Publish a notice in the Federal Register announcing that the guidance document is available;

(C) Post the guidance document on the Internet and make it available in hard copy; and

(D) Implement the guidance document.

(v) After providing an opportunity for comment, FDA may decide that it should issue another draft of the guidance document. In this case, FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section.

(2) FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.

(3) FDA will use the following procedures for developing and issuing Level 1 guidance documents under the circumstances described in paragraph (g)(2) of this section:

(i) After FDA prepares a guidance document, FDA will:

(A) Publish a notice in the Federal Register announcing that the guidance document is available;

(B) Post the guidance document on the Internet and make it available in hard copy;

(C) Immediately implement the guidance document; and

(D) Invite your comment when it issues or publishes the guidance document. Paragraph (h) of this section tells you how to submit your comments.

(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.

(4) FDA will use the following procedures for developing and issuing Level 2 guidance documents:

(i) After it prepares a guidance document, FDA will:

(A) Post the guidance document on the Internet and make it available in hard copy;

(B) Immediately implement the guidance document, unless FDA indicates otherwise when the document is made available; and

(C) Invite your comment on the Level 2 guidance document. Paragraph (h) of this section tells you how to submit your comments.

(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the document when appropriate. If a version is revised, the new version will be placed on the Internet.

(5) You can comment on any guidance document at any time. Paragraph (h) of this section tells you how to submit your comments. FDA will revise guidance documents in response to your comments when appropriate.

(h) How should you submit comments on a guidance document?

(1) If you choose to submit comments on any guidance document under paragraph (g) of this section, you must send them to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(2) Comments should identify the docket number on the guidance document, if such a docket number exists. For documents without a docket number, the title of the guidance document should be included.

(3) Comments will be available to the public in accordance with FDA's regulations on submission of documents to the Dockets Management Branch specified in § 10.20(j).

(i) What standard elements must FDA include in a guidance document?

(1) A guidance document must:

(i) Include the term “guidance,”

(ii) Identify the center(s) or office(s) issuing the document,

(iii) Identify the activity to which and the people to whom the document applies,

(iv) Prominently display a statement of the document's nonbinding effect,

(v) Include the date of issuance,

(vi) Note if it is a revision to a previously issued guidance and identify the document that it replaces, and

(vii) Contain the word “draft” if the document is a draft guidance.

(2) Guidance documents must not include mandatory language such as “shall,” “must,” “required,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.

(3) When issuing draft guidance documents that are the product of international negotiations (e.g., guidances resulting from the International Conference on Harmonisation), FDA need not apply paragraphs (i)(1) and (i)(2) of this section. However, any final guidance document issued according to this provision must contain the elements in paragraphs (i)(1) and (i)(2) of this section.

(j) Who, within FDA, can approve issuance of guidance documents? Each center and office must have written procedures for the approval of guidance documents. Those procedures must ensure that issuance of all documents is approved by appropriate senior FDA officials.

(k) How will FDA review and revise existing guidance documents?

(1) The agency will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.

(2) When significant changes are made to the statute or regulations, the agency will review and, if appropriate, revise guidance documents relating to that changed statute or regulation.

(3) As discussed in paragraph (f)(3) of this section, you may at any time suggest that FDA revise a guidance document.

(l) How will FDA ensure that FDA staff are following GGP's?

(1) All current and new FDA employees involved in the development, issuance, or application of guidance documents will be trained regarding the agency's GGP's.

(2) FDA centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed.

(m) How can you get copies of FDA's guidance documents? FDA will make copies available in hard copy and, as feasible, through the Internet.

(n) How will FDA keep you informed of the guidance documents that are available?

(1) FDA will maintain on the Internet a current list of all guidance documents. New documents will be added to this list within 30 days of issuance.

(2) Once a year, FDA will publish in the Federal Register its comprehensive list of guidance documents. The comprehensive list will identify documents that have been added to the list or withdrawn from the list since the previous comprehensive list.

(3) FDA's guidance document lists will include the name of the guidance document, issuance and revision dates, and information on how to obtain copies of the document.

(o) What can you do if you believe that someone at FDA is not following these GGP's? If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a binding requirement, you should contact that person's supervisor in the center or office that issued the guidance document. If the issue cannot be resolved, you should contact the next highest supervisor. You can also contact the center or office ombudsman for assistance in resolving the issue. If you are unable to resolve the issue at the center or office level or if you feel that you are not making progress by going through the chain of command, you may ask the Office of the Chief Mediator and Ombudsman to become involved.

PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 11. The authority citation for 21 CFR part 14 continues to read as follows: Authority:

§ 14.27 [Amended] 12. In § 14.27(b)(3), remove the word “guidelines” and add in its place the words “guidance documents”. § 14.33 [Amended] 13. In § 14.33(c), remove the word “guidelines” and add in its place the words “guidance documents”.PART 19—STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST 14. The authority citation for 21 CFR part 19 continues to read as follows: Authority:

21 U.S.C. 371.

§ 19.10 [Amended] 15. In § 19.10(c), remove the word “guidelines” and add in its place the words “guidance documents”. PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS 16. The authority citation for 21 CFR part 25 continues to read as follows: Authority:

§ 25.30 [Amended] 17. In § 25.30(h), remove the word “guidelines” and add in its place the words “guidance documents”. PART 101—FOOD LABELING 18. The authority citation for 21 CFR part 101 continues to read as follows: Authority:

15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371.

§ 101.9 [Amended] 19. In § 101.9(b)(7)(vi), remove the word “guideline” wherever it appears and add in its place the words “guidance document”. PART 107—INFANT FORMULA 20. The authority citation for 21 CFR part 107 continues to read as follows: Authority:

21 U.S.C. 321, 343, 350a, 371.

§ 107.270 [Amended] 21. In § 107.270, remove the word “guidelines” and add in its place the word “guidance”. PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 22. The authority citation for 21 CFR part 110 continues to read as follows: Authority:

§ 114.100 [Amended] 25. In § 114.100(a), remove the word “guidelines” and add in its place the words “guidance documents”. PART 170—FOOD ADDITIVES 26. The authority citation for 21 CFR part 170 continues to read as follows: Authority:

21 U.S.C. 321, 341, 342, 346a, 348, 371.

§ 170.39 [Amended] 27. In § 170.39(h), remove the word “guidelines” wherever it appears and add in its place the words “guidance documents”. PART 310—NEW DRUGS 28. The authority citation for 21 CFR part 310 continues to read as follows: Authority:

§ 310.500 [Amended] 29. In § 310.500(e), remove the words “guidelines” and “guideline”, respectively, and add in their place the words “guidance” and “guidance on”, respectively. PART 312—INVESTIGATIONAL NEW DRUG APPLICATION 30. The authority citation for 21 CFR part 312 continues to read as follows: Authority:

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you to comply with certain requirements of this part.

(b) The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) maintain lists of guidance documents that apply to the centers' regulations. The lists are maintained on the Internet and are published annually in the Federal Register. A request for a copy of the CDER list should be directed to the Office of Training and Communications, Division of Communications Management, Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. A request for a copy of the CBER list should be directed to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG 33. The authority citation for 21 CFR part 314 continues to read as follows: Authority:

21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e.

§ 314.50 [Amended] 34. In § 314.50, in the introductory text remove the word “guidelines” and add in its place the words “guidance documents”. § 314.70 [Amended] 35. In § 314.70(a), remove the words “guideline, notice,” and add in their place the word “notice”. § 314.94 [Amended] 36. In § 314.94, in the introductory text remove the words “guidelines” and add in its place the words “guidance documents”. § 314.105 [Amended] 37. In § 314.105(c), remove the word “guidelines” and add in its place the words “guidance documents”. § 314.420 [Amended] 38. In § 314.420(c), remove the words “under § 10.90(b) a guideline” and add in their place the word “guidance”. 39. Revise § 314.445 to read as follows: § 314.445 Guidance documents.

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you to comply with certain requirements of this part.

(b) The Center for Drug Evaluation and Research (CDER) maintains a list of guidance documents that apply to CDER's regulations. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the CDER list should be directed to the Office of Training and Communications, Division of Communications Management, Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

PART 316—ORPHAN DRUGS 40. The authority citation for 21 CFR part 316 continues to read as follows: Authority:

21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.

41. Revise § 316.50 to read as follows: § 316.50 Guidance documents.

FDA's Office of Orphan Products Development will maintain and make publicly available a list of guidance documents that apply to the regulations in this part. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development (HF-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

PART 500—GENERAL 42. The authority citation for 21 CFR part 500 continues to read as follows: Authority:

21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371.

§ 500.80 [Amended] 43. In § 500.80(a), remove the word “guidelines” wherever it appears and add in its place the words “guidance documents”. PART 514—NEW ANIMAL DRUG APPLICATIONS 44. The authority citation for 21 CFR part 514 continues to read as follows: Authority:

21 U.S.C. 351, 352, 360b, 371, 379e, 381.

§ 514.1 [Amended] 45. In § 514.1(d)(2), remove the word “guidelines” wherever it appears and add in its place the words “guidance documents”. PART 601—LICENSING 46. The authority citation for 21 CFR part 601 continues to read as follows: Authority:

(a) FDA has made available guidance documents under § 10.115 of this chapter to help you comply with certain requirements of this part.

(b) The Center for Biologics Evaluation and Research (CBER) maintains a list of guidance documents that apply to the center's regulations. The lists are maintained on the Internet and are published annually in the Federal Register. You may request a copy of the CBER list from the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

PART 803—MEDICAL DEVICE REPORTING 48. The authority citation for 21 CFR part 803 continues to read as follows:Authority:

21 U.S.C. 352, 360, 360i, 360j, 371, 374.

§ 803.14 [Amended] 49. In § 803.14(b), remove the word “guidelines” and add in its place the words “guidance documents”. PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES 50. The authority citation for 21 CFR part 814 continues to read as follows: Authority:

(g) FDA has issued a PMA guidance document to assist the applicant in the arrangement and content of a PMA. This guidance document is available on the Internet at http://www.fda.gov/cdrh/dsma/pmaman/front.html. This guidance document is also available upon request from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818.

PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES 52. The authority citation for 21 CFR part 860 continues to read as follows: Authority:

The Food and Drug Administration (FDA) is announcing a public hearing to discuss certain requirements of the final rule implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (Modernization Act), which published in the Federal Register of December 3, 1999 (64 FR 67720), (hereinafter referred to as the PDMA final rule). The purpose of the hearing is to elicit comment from interested persons, including professional groups and associations, the regulated industry, health care professionals, and consumers, on the potential impact of certain requirements in the PDMA final rule relating to wholesale distribution of prescription drugs by distributors that are not authorized distributors of record, and distribution of blood derivatives by entities that meet the definition of a “health care entity” in the PDMA final rule. The agency will use information obtained from the hearing and the comments to this document to determine what steps, if any, should be taken to modify the requirements in the PDMA final rule.

DATES:

The public hearing will be held on Friday, October 27, 2000, from 8:30 a.m. to 4:30 p.m. Submit written notices of participation and comments for consideration at the hearing to the docket number listed in the heading of this document by October 13, 2000.1 Written comments will be accepted after the hearing until November 20, 2000.

1 Until recently, two dockets were being used to receive comments on issues related to PDMA. One docket, the docket established in 1988, will no longer be used. For simplicity, all comments related to any issues involving PDMA should be forwarded to the docket listed in the heading of this document.

ADDRESSES:

The public hearing will be held at 5630 Fishers Lane, rm. 1066, Rockville, MD 20852. Submit written notices of participation to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should also be submitted to the Dockets Management Branch (address above). Transcripts of the hearing will be available for review at the Dockets Management Branch (address above).

PDMA, as amended by the PDA, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, 381) to, among other things, establish requirements for the wholesale distribution of prescription drugs; and to prohibit, with certain exceptions, the sale or offer to sell prescription drugs that have been purchased by a hospital or other health care entity or that have been donated or supplied at a reduced price to a charitable organization.

Section 503(e)(1)(A) of the act states that each person who is engaged in the wholesale distribution of a prescription drug who is not the manufacturer or an authorized distributor of record for the drug must, before each wholesale distribution of a drug, provide to the person receiving the drug a statement, also known as a drug “pedigree,” (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of the drug, including the date of the transaction and the names and addresses of all parties to the transaction. Section 503(e)(4)(A) of the act states that, for the purposes of section 503(e), the term “authorized distributors of record” means those distributors with whom a manufacturer has established an “ongoing relationship” to distribute the manufacturer's products.

In the PDMA final rule, the agency published regulations in part 203 (21 CFR part 203) implementing these and other provisions of PDMA. Section 203.50 implements section 503(e)(1)(A) of the act and requires that, before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller must provide to the purchaser a statement identifying each prior sale, purchase, or trade of the drug. The identifying statement must include the proprietary and established name of the drug, its dosage, the container size, the number of containers, lot or control numbers of the drug being distributed, the business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer, and the date of each previous transaction. Section 203.3(b) defines “authorized distributor of record” as a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. “Ongoing relationship” is defined in § 203.3(u) to mean an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments. If the distributor is not authorized to distribute a manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute.

Thus, the PDMA final rule requires unauthorized distributors (i.e., those distributors who do not have a written authorization agreement) to provide a drug statement, or pedigree, to purchasers showing the entire prior sales history of the drug back to the first sale by the manufacturer. As discussed in the preamble to the PDMA final rule (64 FR 67720 at 67747), manufacturers and authorized distributors of record are not required to provide an identifying statement when selling a drug, although the agency encouraged them to do so voluntarily to permit unauthorized distributors to continue to be able to purchase products from them.2

2 An unauthorized wholesale distributor that purchases a product from a manufacturer or authorized distributor of record without an identifying statement showing the prior sales of the drug could not provide an identifying statement to its purchasers and, therefore, could not conduct further wholesale transactions of the drug in compliance with § 203.50.

The provisions in the PDMA final rule related to wholesale distribution of prescription drugs by unauthorized distributors (i.e., §§ 203.3(u) and 203.50) were adopted from the provisions in the proposed rule published in the Federal Register of March 14, 1994 (59 FR 11842), and are essentially the same as the proposed provisions, except the definition for “ongoing relationship” in the proposed rule was revised to eliminate certain requirements.3 The agency received two comments on the proposed definition of ongoing relationship and one comment on proposed § 203.50, and responded in detail to those comments in the preamble to the PDMA final rule (see 64 FR 67720 at 67727, 67728, and 67747).

3 The proposed rule defined “ongoing relationship” to require a written agreement and, in addition, the following two requirements that were eliminated in the final rule: (1) That a sale be completed under the written agreement and (2) that the distributor be listed on the manufacturer's list of authorized distributors.

Section 503(c)(3)(A) of the act states that no person may sell, purchase, or trade, or offer to sell, purchase, or trade, any prescription drug that was purchased by a public or private hospital or other health care entity. Section 503(c)(3)(B) of the act states several exceptions to section 503(c)(3)(A), none of which are relevant to this discussion. Section 503(c)(3) of the act also states that “[f]or purposes of this paragraph, the term ‘entity’ does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law * * *.”

Sections 203.20 of the PDMA final rule provides, with certain exceptions, that no person may sell, purchase, or trade, or offer to sell, purchase, or trade any prescription drug that was purchased by a public or private hospital or other health care entity or donated or supplied at a reduced price to a charitable institution. In § 203.3(q) of the PDMA final rule, “Health care entity” is defined as meaning any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or wholesale distributor. Under both the act and the PDMA final rule, a person could not simultaneously be a health care entity and a retail pharmacy or wholesale distributor. Thus, under the PDMA final rule, blood centers functioning as health care entities could not engage in wholesale distribution of prescription drugs, except for blood and blood components intended for transfusion, which are exempt from PDMA under § 203.1 of the PDMA final rule. Blood and blood components include whole blood, red blood cells, platelets, and cryoprecipitated antihemophilic factor, which are prepared by blood banks who collect blood from donors and separate out the components using physical or mechanical means. Blood derivatives are derived from human blood, plasma, or serum through a chemical fractionation manufacturing process. Examples of blood derivative products include albumin, antihemophilic factor, immune globulin, and alpha-1 anti-tripsin. As discussed in the preamble to the PDMA final rule in response to comments (64 FR 67720 at 67725 through 67727), blood derivative products are not blood or blood components intended for transfusion and therefore could not be distributed by health care entities, including full service blood centers that function as health care entities, after the final rule goes into effect. The agency received several comments on the proposed rule objecting to the applicability of the sales restrictions to the sale of blood derivatives by blood centers that function as health care entities, and responded in detail to those comments (see 64 FR 67720 at 67726).

C. Events Leading to the Delay of the Effective Date; Need for the Public Hearing

After publication of the PDMA final rule, the agency received letters and petitions and had other communications with industry, industry trade associations, and members of Congress objecting to the provisions in §§ 203.3(u) and 203.50. On March 29, 2000,4 the agency met with representatives from the wholesale drug industry and industry associations. The meeting participants discussed their concerns with both: (1) The requirement in § 203.3(u) that there be a written authorization agreement between a manufacturer and distributor for the distributor to be considered an authorized distributor of record under § 203.3(b), and (2) the requirement in § 203.50 that unauthorized distributors provide a pedigree showing all prior sales going back to the manufacturer.

4 In a document published in the Federal Register of May 3, 2000 (65 FR 25639 at 25640), the agency incorrectly stated that this meeting occurred in early February 2000.

The meeting participants asserted that manufacturers are unwilling to enter into written authorization agreements with the majority of smaller wholesalers. As a result, these wholesalers cannot become authorized distributors of record for the drugs they sell. The meeting participants also said that smaller wholesalers cannot obtain the required pedigree showing all prior sales of the drugs they purchase for sale because a large portion of these drugs are purchased from authorized distributors who are not required to provide a pedigree and who are unwilling to voluntarily provide them. The meeting participants asserted that authorized distributors will not voluntarily provide pedigrees when they sell drugs to unauthorized distributors because it would require them to change their warehouse and business procedures, which would entail additional effort and expense.

The meeting participants asserted that implementation of the PDMA final rule will prevent over 4,000 smaller, unauthorized distributors from distributing drugs to their customers and may put them out of business, at least with respect to their prescription drug wholesale business. They also asserted that because many of their customers are smaller retail outlets that are not served by larger distributors, implementation of the PDMA final rule may leave certain markets for prescription drugs, and ultimately consumers for prescription drugs, underserved.

In addition to the meeting discussed above and other informal communications that FDA has had with industry, industry associations, and Congress, FDA received a petition for stay of action requesting that the relevant provisions of the PDMA final rule be stayed until October 1, 2001. That petition was supported by numerous letters submitted to the docket from entities that would be considered unauthorized distributors under the PDMA final rule. The agency also received a petition for reconsideration from the Small Business Administration (SBA) requesting that FDA reconsider the PDMA final rule and suspend its effective date based on the projected severe economic impact it would have on over 4,000 small businesses. The petitions argued that the requirement for a written agreement in § 203.3(u) is unreasonable because manufacturers are not willing to enter into such agreements with the majority of smaller distributors. The petitions also asserted that authorized wholesalers are not now able and could not provide, at a reasonable cost, a pedigree to their unauthorized distributor customers that meets the requirements of § 203.50 of the PDMA final rule. The SBA petition asserted that, if the effective date of the PDMA final rule is not stayed, drug products now in the inventory of wholesalers will have to be cleared and new orders will have to cease or be severely limited to comply with the PDMA final rule's December 4, 2000, effective date, with corresponding disruptions in the distribution of drugs possible by summer 2000.

In addition to the submissions on wholesale distribution by unauthorized distributors, the agency has received several letters on, and has held several meetings to discuss, the implications of the final regulations on blood centers that distribute blood derivative products and provide health care as a service to the hospitals and patients they serve. The blood center industry asserts that the regulations and, particularly the definition of “health care entity,” will severely inhibit their ability to provide full service care to the detriment of client hospitals and the patients they serve, and may disrupt the distribution of these products to the public. The agency also received a letter from Congress on this issue.

Based on the concerns expressed by industry, industry associations, and Congress about implementing §§ 203.3(u) and 203.50 by the December 4, 2000, effective date, the agency published a document in the Federal Register of May 3, 2000 (65 FR 25639), delaying the effective date for those provisions until October 1, 2001 (the May 2000 document). In addition, the May 2000 document delayed the applicability of § 203.3(q) to wholesale distribution of blood derivatives by health care entities until October 1, 2001. The May 2000 document also reopened the administrative record and gave interested persons until July 3, 2000, to submit written comments. As stated in the May 2000 document, the purpose of delaying the effective date for these provisions was to give the agency time to obtain more information about the possible consequences of implementing them and to further evaluate the issues involved.

On May 16, 2000, the House Committee on Appropriations (the Committee) stated in its report accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2001 (report 106-619) that it supported the “recent FDA action to delay the effective date for implementing certain requirements of the Prescription Drug Marketing Act until October 1, 2001 and reopen the administrative record in order to receive additional comments.” In addition, the Committee stated that it “believes the agency should thoroughly review the potential impact of the proposed provisions on the secondary wholesale pharmaceutical industry.” The Committee directed the agency to provide a report to the Committee by January 15, 2001, summarizing the comments and issues raised and agency plans to address the concerns.

In light of the complexity of the issues involved and the potentially serious economic and public health consequences that implementation of the relevant provisions of the PDMA final rule may have, the agency believes that it is appropriate to hold a public meeting to solicit information from, and the views of, interested persons, including professional groups and associations, the regulated industry, health care professionals, and consumers. This will help to develop an adequate factual basis that the agency can use to determine whether it is in the public health interest to take steps to modify or change the requirements in the PDMA final rule.

II. Scope of the Hearing

The PDMA final rule provisions discussed in this document raise many complex economic and public health issues. To promote a more useful discussion at the public hearing, FDA has developed the following list of questions, which are of specific interest. This list is not intended to be exclusive, and presentations and comments answering other questions or addressing other issues, to the extent that they are pertinent to the PDMA final rule provisions discussed in this document, are encouraged.

A. Questions on Distribution of Prescription Drugs by Unauthorized Distributors

1. How does the PDMA final rule, as published, affect the ability of unauthorized distributors to engage in drug distribution, i.e., what specific requirements would be difficult or impossible for unauthorized distributors to meet? Why?

2. If the PDMA final rule diminished the ability of unauthorized distributors to engage in drug distribution, what effect would this have on the drug distribution system? What, if any, adverse public health consequences would result? What would be the economic costs to manufacturers, distributors (authorized and unauthorized), and consumers of drugs?

3. If the act were amended by Congress to delete the requirement for provision of a drug pedigree by unauthorized distributors, would there be an increased risk of distribution of counterfeit, expired, adulterated, misbranded, or otherwise unsuitable drugs to consumers and patients?

4. If the act were amended by Congress to require authorized distributors to provide a pedigree, what types of additional costs and burdens would they incur?

5. Could specific changes be made to the information that is required under § 203.50 to appear on a pedigree to make it more practical, from an authorized distributor's standpoint, to voluntarily provide a pedigree? Would use of a standardized government form be helpful?

6. If actual sales by a manufacturer to a distributor were used by FDA as the only criterion to determine whether an ongoing relationship exists between them (and as a result, whether the distributor is an authorized distributor of record), would it result in more distributors being authorized than if a written authorization agreement is required? What other types of criteria might be used by FDA to make this determination?

B. Questions on Distribution of Blood Derivatives by Blood Banks and Other Health Care Entities

1. What distribution systems are available for blood derived products? Do these distribution systems differ from those for other types of prescription drugs? If so, how?

2. What effect would the PDMA final rule, as published, have on the distribution system for blood derived products? What, if any, adverse public health consequences would result? What would be the economic costs to manufacturers, distributors, and consumers of blood derived products?

3. If blood derived products were excluded from the sales restrictions (i.e., if such products were permitted to be sold by health care entities), would there be an increased risk of distribution of counterfeit, expired, adulterated, misbranded, or otherwise unsuitable blood derived products to consumers and patients? Why or why not?

4. Do manufacturers of blood derived products provide these products to health care entities, particularly those that are also charitable organizations, at a lower price when compared to other customers? Do manufacturers sell these products to charitable or for profit health care entities with the understanding that the products will be used for patients of the purchasing health care entity and will not be resold to other health care entities, distributors, or retail pharmacies?

III. Notice of Hearing Under 21 CFR Part 15

The Commissioner of Food and Drugs (the Commissioner) is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The presiding officer will be the Commissioner or her designee. The presiding officer will be accompanied by a panel of FDA employees with relevant expertise.

Persons who wish to participate in the part 15 hearing must file a written notice of participation with the Dockets Management Branch (address above) prior to October 13, 2000. To ensure timely handling, any outer envelope should be clearly marked with the Docket No. 92N-0297 and the statement “FDA PDMA Hearing.” Groups should submit two copies. The notice of participation should contain the person's name; address; telephone number; affiliation, if any; the sponsor of the presentation (e.g., the organization paying travel expenses or fees), if any; brief summary of the presentation; and approximate amount of time requested for the presentation. The agency requests that interested persons and groups having similar interests consolidate their comments and present them through a single representative. FDA will allocate the time available for the hearing among the persons who file notices of participation as described above. If time permits, FDA may allow interested persons attending the hearing who did not submit a written notice of participation in advance to make an oral presentation at the conclusion of the hearing.

After reviewing the notices of participation and accompanying information, FDA will schedule each appearance and notify each participant by telephone of the time allotted to the person and the approximate time the person's oral presentation is scheduled to begin. The hearing schedule will be available at the hearing. After the hearing, the hearing schedule will be placed on file in the Dockets Management Branch under Docket No. 92N-0297.

Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation.

Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). The transcript of the hearing will be available on the Internet at http://www.fda.gov/ohrms/dockets and orders for copies of the transcript can be placed at the meeting or through the Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

Any handicapped persons requiring special accommodations to attend the hearing should direct those needs to the contact person listed above.

To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h).

IV. Request for Comments

Interested persons may submit to the Dockets Management Branch (address above) written notices of participation and comments for consideration at the hearing by October 13, 2000. To permit time after the hearing for all interested persons to submit data, information, or views on this subject, the administrative record of the hearing will remain open following the hearing until November 20, 2000. Persons who wish to provide additional materials for consideration should file these materials with the Dockets Management Branch (address above) by November 20, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy.

Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

This document contains corrections to a removal of temporary regulations that provides that an individual Federal income tax return completed as part of the Telefile Voice Signature test will be treated as a return that is signed, authenticated, verified and filed by the taxpayer. This document was published in the Federal Register on July 18, 2000 (65 FR 44437).

DATES:

This correction is effective July 18, 2000.

FOR FURTHER INFORMATION CONTACT:

Beverly A. Baughman (202) 622-4940 (not a toll-free number).

SUPPLEMENTARY INFORMATION:Need for Correction

As published, the removal of temporary regulations (TD 8892) contains errors that may prove to be misleading and is in need of clarification.

This document provides required notice of substantive rules adopted by the Coast Guard and temporarily effective between April 1, 2000 and June 30, 2000 which were not published in the Federal Register. This quarterly notice lists temporary local regulations, drawbridge regulations, security zones, and safety zones of limited duration and for which timely publication in the Federal Register was not possible.

DATES:

This notice lists temporary Coast Guard regulations that became effective and were terminated between April 1, 2000 and June 30, 2000.

ADDRESSES:

The Docket Management Facility maintains the public docket for this notice. Documents indicated in this notice will be available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, Room PL-401, 400 Seventh Street SW., Washington, DC 20593-0001 between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may electronically access the public docket for this notice on the Internet at http://dms.dot.gov.

FOR FURTHER INFORMATION CONTACT:

For questions on this notice, contact Lieutenant Bruce Walker, Office of Regulations and Administrative Law, telephone (202) 267-6233. For questions on viewing, or on submitting material to the docket, contact Dorothy Beard, Chief, Dockets, Department of Transportation (202) 866-9329.

SUPPLEMENTARY INFORMATION:

District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety needs of the waters within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to vessels, ports, or waterfront facilities to prevent injury or damage. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Timely publication of these regulations in the Federal Register is often precluded when a regulation responds to an emergency, or when an event occurs without sufficient advance notice. However, the affected public is informed of these regulations through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the regulation. Because mariners are notified by Coast Guard officials on-scene prior to enforcement action, Federal Register notice is not required to place the special local regulation, security zone, or safety zone in effect. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense to the public, the Coast Guard periodically publishes a list of these temporary special local regulations, security zones, and safety zones. Permanent regulations are not included in this list because they are published in their entirety in the Federal Register. Temporary regulations may also be published in their entirety if sufficient time is available to do so before they are placed in effect or terminated. The safety zones, special local regulations, drawbridge regulations and security zones listed in this notice have been exempted from review under Executive Order 12866 because of their emergency nature, or limited scope and temporary effectiveness.

The following regulations were placed in effect temporarily during the period April 1, 2000 and June 30, 2000, unless otherwise indicated.

In the Saint Lawrence Seaway Development Corporation (SLSDC) Final Rule amending the Seaway Regulations and Rules (33 CFR part 401) published in the Federal Register on August 31, 2000 (65 FR 52912), inadvertent errors were made in the amended authority citation and in the amendment to paragraph § 401.90(c)(2). This document corrects those errors.

In the Saint Lawrence Seaway Development Corporation (SLSDC) Final Rule amending the Seaway Regulations and Rules (33 CFR part 401) published in the Federal Register on August 31, 2000 (65 FR 52912), inadvertent errors were made in the amended authority citation and in the amendment to § 401.90(c)(2). In the authority citation, “49 CFR 1.50a” should have been “49 CFR 1.52(a)”. In § 401.90(c)(2) the word “reasonable” should have been “reasonably”. This correction makes those changes.

In rule SLSDC 2000-7543 published in the Federal Register on August 31, 2000 (65 FR 52912), make the following corrections: 1. On page 52913, in the second column, in the amendment to the authority citation (amendment 1), remove “49 CFR 1.50a” and add in its place “49 CFR 1.52(a)”. 2. On page 52915, in the second column, in the amendment to § 401.90(c)(2) (included in amendment 25), remove “reasonable” and add in its place “reasonably”. Issued at Washington, DC on September 14, 2000. Saint Lawrence Seaway Development Corporation. Marc C. Owen,Chief Counsel. [FR Doc. 00-24034 Filed 9-18-00; 8:45 am] BILLING CODE 4910-61-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [CA 226-0251; FRL-6868-9] Revisions to the California State Implementation Plan, Tehama County Air Pollution Control District AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is finalizing limited approval and limited disapproval of revisions to the Tehama County Air Pollution Control District (TCAPCD) portions of the California State Implementation Plan (SIP). The actions were proposed in the Federal Register on April 17, 2000, and concern control of emissions of oxides of nitrogen (NOX) from industrial, institutional, and commercial boilers, steam generators, and process heaters, stationary piston engines, and stationary gas turbines. Under authority of the Clean Air Act as amended in 1990 (CAA or the Act), this action simultaneously approves local rules that regulate these emission sources and directs California to correct rule deficiencies.

EFFECTIVE DATE:

This rule is effective on October 19, 2000.

ADDRESSES:

You can inspect copies of the administrative record for this action at EPA's Region IX office during normal business hours. You can inspect copies of the submitted SIP revisions at the following locations:

On April 17, 2000 (65 FR 20423), EPA proposed a limited approval and limited disapproval of the following rules that were submitted for incorporation into the California SIP.

Air pollution agency Rule # Rule title Adopted Submitted Tehama County Air Pollution Control District4.31Industrial, Institutional, and Commercial Boilers, Steam Generators, and Process Heaters03/14/955/13/99 Tehama County Air Pollution Control District4.34Stationary Piston Engines06/03/97 5/13/99 Tehama County Air Pollution Control District4.37Determination of Reasonably Available Control Technology for the Control of Oxides of Nitrogen from Stationary Gas Turbines04/21/985/13/99

We proposed a limited approval because we determined that these rules improve the SIP and are largely consistent with the relevant CAA requirements. We simultaneously proposed a limited disapproval because some rule provisions conflict with section 110 and part D of the Act. These provisions include the following:

Rule 4.31 and Rule 4.37 allow APCO discretion as to approval of units that are exempt from RACT emission requirements due to lack of technical or economic feasibility. Rule 4.31 allows unapprovable APCO discretion as to schedule of periodic compliance determinations. Rule 4.34 allows APCO discretion in approving the use of alternate portable analyzers.

Our proposed action contains more information on the basis for this rulemaking and on our evaluation of the submittals.

Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, EPA is finalizing a limited approval of the submitted rules. This action incorporates the submitted rules into the California SIP, including those provisions identified as deficient. As authorized under section 110(k)(3), EPA is simultaneously finalizing a limited disapproval of the rules. As a result, sanctions will be imposed unless EPA approves subsequent SIP revisions that correct the rules deficiencies within 18 months of the effective date of this action. These sanctions will be imposed under section 179 of the Act according to 40 CFR 52.31. In addition, EPA must promulgate a federal implementation plan (FIP) under section 110(c) unless we approve subsequent SIP revisions that correct the rule deficiencies within 24 months. Note that the submitted rules have been adopted by the Tehama County Air Pollution Control District, and EPA's final limited disapproval does not prevent the local agency from enforcing them.

IV. Administrative Requirements A. Executive Order 12866

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order (E.O.) 12866, entitled “Regulatory Planning and Review.”

B. Executive Order 13045

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to E.O. 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

C. Executive Order 13084

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, E.O. 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of E.O. 13084 do not apply to this rule.

D. Executive Order 13132

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. E.O. 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under E.O. 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in E.O. 13132, because it merely acts on a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

E. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply act on requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

EPA's disapproval of the state request under section 110 and subchapter I, part D of the Clean Air Act does not affect any existing requirements applicable to small entities. Any pre-existing federal requirements remain in place after this disapproval. Federal disapproval of the state submittal does not affect state enforceability. Moreover, EPA's disapproval of the submittal does not impose any new Federal requirements. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

F. Unfunded Mandates

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action acts on pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

G. National Technology Transfer and Advancement Act

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

EPA believes that VCS are inapplicable to today's action because it does not require the public to perform activities conducive to the use of VCS.

H. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

I. Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 20, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Dated: August 3, 2000.John Wise, Acting Regional Administrator, Region IX.Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority:

This document revises the list of vehicles not originally manufactured to conform to the Federal motor vehicle safety standards that NHTSA has decided to be eligible for importation. This list is contained in an appendix to the agency's regulations that prescribe procedures for import eligibility decisions. The revised list includes all vehicles that NHTSA has decided to be eligible for importation since October 1, 1999. NHTSA is required by statute to publish this list annually in the Federal Register.

Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable Federal motor vehicle safety standards shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable Federal motor vehicle safety standards. Where there is no substantially similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle to be admitted into the United States if its safety features comply with, or are capable of being altered to comply with, all applicable Federal motor vehicle safety standards based on destructive test data or such other evidence as the Secretary of Transportation decides to be adequate.

Under 49 U.S.C. 30141(a)(1), import eligibility decisions may be made “on the initiative of the Secretary of Transportation or on petition of a manufacturer or importer registered under [49 U.S.C. 30141(c)].” The Secretary's authority to make these decisions has been delegated to NHTSA. The agency publishes notice of eligibility decisions as they are made.

Under 49 U.S.C. 30141(b)(2), a list of all vehicles for which import eligibility decisions have been made must be published annually in the Federal Register. On October 1, 1996, NHTSA added the list as an appendix to 49 CFR Part 593, the regulations that establish procedures for import eligibility decisions (61 FR 51242). As described in the notice, NHTSA took that action to ensure that the list is more widely disseminated to government personnel who oversee vehicle imports and to interested members of the public. See 61 FR 51242-43. In the notice, NHTSA expressed its intention to annually revise the list as published in the appendix to include any additional vehicles decided by the agency to be eligible for importation since the list was last published. See 61 FR 51243. The agency stated that issuance of the document announcing these revisions will fulfill the annual publication requirements of 49 U.S.C. 30141(b)(2). Ibid.

This rulemaking action was not reviewed under Executive Order 12866. NHTSA has analyzed this rulemaking action and determined that it is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures.

2. Regulatory Flexibility Act

In accordance with the Regulatory Flexibility Act, NHTSA has evaluated the effects of this action on small entities. Based upon this evaluation, I certify that the revisions resulting from this rulemaking will not have a significant economic impact on a substantial number of small entities. Accordingly, the agency has not prepared a regulatory flexibility analysis.

Because this rulemaking does not impose any regulatory requirements, but merely furnishes information by revising the list in the Code of Federal Regulations of vehicles for which import eligibility decisions have been made, it has no economic impact.

3. Executive Order 12612 (Federalism)

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this rule does not have sufficient Federalism implications to warrant preparation of a Federalism Assessment. No State laws will be affected.

4. National Environmental Policy Act

The agency has considered the environmental implications of this rule in accordance with the National Environmental Policy Act of 1969 and determined that it will not significantly affect the human environment.

5. Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1980, P.L. 96-511, the agency notes that there are no information collection requirements associated with this rulemaking action.

6. Civil Justice Reform

This rule does not have any retroactive effect. It does not repeal or modify any existing Federal regulations. A petition for reconsideration or other administrative proceeding will not be a prerequisite to an action seeking judicial review of this rule. This rule does not preempt the states from adopting laws or regulations on the same subject, except that it will preempt a state regulation that is in actual conflict with the Federal regulation or makes compliance with the Federal regulation impossible or interferes with the implementation of the Federal statute.

7. Notice and Comment

NHTSA finds that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this action does not impose any regulatory requirements, but merely revises the list of vehicles not originally manufactured to conform to the Federal motor vehicle safety standards that NHTSA has decided to be eligible for importation into the United States to include all vehicles for which such decisions have been made since October 1, 1999.

In addition, so that the list of vehicles for which import eligibility decisions have been made may be included in the next edition of 49 CFR Parts 400 to 999, which is due for revision on October 1, 2000, good cause exists to dispense with the requirement in 5 U.S.C. § 553(d) for the effective date of the rule to be delayed for at least 30 days following its publication.

List of Subjects in 49 CFR Part 593

Imports, Motor vehicle safety, Motor vehicles.

In consideration of the foregoing, Part 593 of Title 49 of the Code of Federal Regulations, Determinations that a vehicle not originally manufactured to conform to the Federal Motor Vehicle Safety Standards is eligible for importation, is amended as follows: PART 593—[AMENDED] 1. The authority citation for part 593 continues to read as follows: Authority:

49 U.S.C. 322 and 30141(b); delegation of authority at 49 CFR 1.50

2. Appendix A to Part 593 is revised to read as follows: Appendix A to Part 593—List of Vehicles Determined To Be Eligible for Importation

Each vehicle on the following list is preceded by a vehicle eligibility number. The importer of a vehicle admissible under any eligibility decision must enter that number on the HS-7 Declaration Form accompanying entry to indicate that the vehicle is eligible for importation.

“VSA” eligibility numbers are assigned to all vehicles that are decided to be eligible for importation on the initiative of the Administrator under Sec. 593.8.

“VSP” eligibility numbers are assigned to vehicles that are decided to be eligible under Sec. 593.7(f), based on a petition from a manufacturer or registered importer submitted under Sec. 593.5(a)(1), which establishes that a substantially similar U.S.-certified vehicle exists.

“VCP” eligibility numbers are assigned to vehicles that are decided to be eligible under Sec. 593.7(f), based on a petition from a manufacturer or registered importer submitted under Sec. 593.5(a)(2), which establishes that the vehicle has safety features that comply with, or are capable of being altered to comply with, all applicable Federal motor vehicle safety standards.

Vehicles for which eligibility decisions have been made are listed alphabetically by make, with the exception of Mercedes-Benz vehicles, which appear at the end of the list. Eligible models within each make are listed numerically by “VSA,” “VSP,” or “VCP” number.

All hyphens used in the Model Year column mean “through” (for example, “1973-1989” means “1973 through 1989”).

The initials “MC” used in the Manufacturer column mean “motorcycle.”

The initials “SWB” used in the Model Type column mean “Short Wheel Base.”

The initials “LWB” used in the Model Type column mean “Long Wheel Base.”

This document adopts fees for Fiscal Year 2001 and until further notice, as authorized by 49 U.S.C. 30141, relating to the registration of importers and the importation of motor vehicles not certified as conforming to the Federal motor vehicle safety standards (FMVSS).

We are increasing the fee for the registration of a new importer from $491 to $584, and the annual fee authorized by statute from $350 to $416. These fees include the costs of maintaining the registered importer (RI) program. The fee required to reimburse the U.S. Customs Service for conformance bond processing costs will increase from $5.40 to $5.75 per bond.

The fee payable for a petition seeking a determination that a nonconforming vehicle is capable of conversion to meet the FMVSS will be reduced from $199 to $175 if the nonconforming vehicle is substantially similar to conforming vehicles. With respect to vehicles that have no substantially similar counterpart, the petition fee increases from $721 to $800. In addition, the fee payable by the importer of each “substantially similar” vehicle that benefits from an eligibility determination will be reduced to $105 but remain at $125 for vehicles not “substantially similar,” regardless of whether the determination is made pursuant to a petition or by NHTSA on its own initiative. This fee does not apply to vehicles imported from Canada admitted under VSA 80-83, or to vehicles imported on and after October 1, 2000 that are covered by determinations that were made on the agency's own initiative before October 1, 2000, for which all costs have now been recovered.

Finally, the $16 fee that a RI must pay as a processing cost for review of each conformity package that it submits will remain at $16. However, if the RI files the HS-7 Declaration form for the vehicle electronically with the U.S. Customs Service though the Automated Broker Interface, and the RI has an e-mail address and pays by credit card, the present fee of $13 will be reduced to $6 per vehicle if the information in the entry and certificate is correct.

On June 24, 1996, at 61 FR 32411, we published a notice that discussed in full the rulemaking history of 49 CFR part 594 and the fees authorized by the Imported Vehicle Safety Compliance Act of 1988, Public Law 100-562, since recodified as 49 U.S.C. 30141-47. The reader is referred to that notice for background information relating to this rulemaking action. Certain fees were initially established to become effective January 31, 1990, and have been in effect and occasionally modified since then.

The fees applicable in any fiscal year are to be established before the beginning of such year. On July 19, 2000, we proposed fees that would become effective on October 1, 2000, the beginning of FY 2001 (65 FR 44713). There were no comments on this notice.

The statute authorizes fees to cover the costs of the importer registration program, to cover the cost of making import eligibility determinations, and to cover the cost of processing the bonds furnished to the Customs Service. We last amended the fee schedule in 1998; it has applied in Fiscal Years 1999-2000.

The fees are based on actual time and costs associated with the tasks for which the fees are assessed and reflect the slight increase in hourly costs in the past two fiscal years attributable to the approximately 3.68 and 4.94 percent raise (including the locality adjustment for Washington, DC) in salaries of employees on the General Schedule that became effective on January 1 each year in the years 1999 and 2000.

Requirements of the Fee Regulation Section 594.6—Annual Fee for Administration of the Importer Registration Program

Section 30141(a)(3) of Title 49 U.S.C. provides that RIs must pay “the annual fee the Secretary of Transportation establishes * * * to pay for the costs of carrying out the registration program for importers * * *.” This fee is payable both by new applicants and by existing RIs. In order for it to maintain its registration, at the time it submits its annual fee, each RI must also file a statement affirming that the information it previously furnished in its registration application (or as later amended) remains correct (49 CFR 592.5(e)).

In accordance with the statutory directive, we reviewed the existing fees and their bases in an attempt to establish fees which would be sufficient to recover the costs of carrying out the registration program for importers for at least the next two fiscal years. The initial component of the Registration Program Fee is the fee attributable to processing and acting upon registration applications. We will increase this fee from $290 to $345 for new applications. We will increase the fee representing the review of the annual statement from $149 to $177. The adjustments reflect our recent experience in time spent reviewing both new applications and annual statements with accompanying documentation, as well as the inflation factor attributable to Federal salary increases and locality adjustments in the past two years since the regulation was last amended.

We must also recover costs attributable to maintenance of the registration program which arise from our need to review a registrant's annual statement and to verify the continuing validity of information already submitted. These costs also include anticipated costs attributable to possible revocation or suspension of registrations.

Based upon our review of the costs associated with this program, the portion of the fee attributable to the maintenance of the registration program is approximately $239 for each RI, an increase of $38. When this $239 is added to the $345 representing the registration application component, the cost to an applicant equals $584, which is the fee we are adopting. This represents an increase of $93 from the existing fee. When the $239 is added to the $177 representing the annual statement component, the total cost to the RI is $416, which represents an increase of $66.

Section 594.6(h) recounts indirect costs that were previously estimated at $12.12 per man-hour. This will be raised $1.78, to $13.90, based on the agency costs discussed above.

Section 30141(a)(3) also requires registered importers to pay “other fees the Secretary of Transportation establishes to pay for the costs of * * * (B) making the decisions under this subchapter.” This includes decisions on whether the vehicle sought to be imported is substantially similar to a motor vehicle originally manufactured for import into and sale in the United States, and certified as meeting the FMVSS, and whether it is capable of being readily altered to meet those standards. Alternatively, where there is no substantially similar U.S. motor vehicle, the decision is whether the safety features of the vehicle comply with or are capable of being altered to comply with the FMVSS. These decisions are made in response to petitions submitted by RIs or manufacturers, or pursuant to the Administrator's initiative.

The fee for a vehicle imported under an eligibility decision made pursuant to a petition is payable in part by the petitioner and in part by other importers. The fee to be charged for each vehicle is the estimated pro rata share of the costs in making all the eligibility determinations in a fiscal year.

Inflation and the small raises under the General Schedule also must be taken into account in the computation of costs. However, we have been able to reduce our processing costs through combining several decisions in a single Federal Register notice as well as achieving efficiencies through improved word processing techniques. Accordingly, we are reducing the fee of $199 presently required to accompany a “substantially similar” petition to $175, but are increasing from $721 to $800 the fee for petitions for vehicles that are not substantially similar and that have no certified counterpart. In the event that a petitioner requests an inspection of a vehicle, the fee for such an inspection remains at $550 for each of those types of petitions.

The importer of each vehicle determined to be eligible for importation pursuant to a petition currently must pay $125 upon its importation, the same fee applicable to those whose vehicles covered by an eligibility determination on the agency's initiative (other than vehicles imported from Canada that are covered by code VSA 80-83, for which no eligibility determination fee is assessed). This fee will change due to the different costs associated with petitions. For petitions based on non-substantially similar vehicles, the fee will remain at $125. For petitions based on substantially similar vehicles, the fee will be reduced from $125 to $105. Costs associated with previous eligibility determinations on the agency's own initiative will have been recovered by October 1, 2000. We shall apply the fee of $125 per vehicle only to vehicles covered by determinations made by the agency on its own initiative on and after October 1, 2000.

Section 594.9—Fee to Recover the Costs of Processing the Bond

Section 30141(a)(3) also requires a registered importer to pay “any other fees the Secretary of Transportation establishes * * * to pay for the costs of—(A) processing bonds provided to the Secretary of the Treasury” upon the importation of a nonconforming vehicle to ensure that the vehicle will be brought into compliance within a reasonable time or if the vehicle is not brought into compliance within such time, that it is exported, without cost to the United States, or abandoned to the United States.

The statute contemplates that we will make a reasonable determination of the cost to the United States Customs Service of processing the bond. In essence, the cost to Customs is based upon an estimate of the time that a GS-9, Step 5 employee spends on each entry, which Customs has judged to be 20 minutes.

Because of the modest salary and locality raises in the General Schedule that were effective at the beginning of 1999 and 2000, we are increasing the current processing fee by $0.35, from $5.40 per bond to $5.75.

Section 594.10 Fee for review and processing of conformity certificate

This fee currently requires each RI to pay $16 per vehicle to cover the cost of the agency's review of the certificate of conformity furnished to the Administrator. However, if a RI enters a vehicle with the U.S. Customs Service through the Automated Broker Interface (ABI), has an e-mail address to receive communications from NHTSA, and pays the fee by credit card, the fee is $13. Based upon an analysis of the direct and indirect costs for the review and processing of these certificates, we find that the costs continue to average $16 per vehicle for non-automated entries, and we therefore did not propose a change in this fee. We estimate that there has been a reduction in cost to the agency for automated entries of approximately $7, and we will pass this on to the RI by reducing the fee from $13 to $6 per vehicle if all the information in the ABI entry is correct. Because errors in ABI entries eliminate the time-saving advantages of electronic entry, the processing cost will remain at $16 for certificates of conformity or ABI entries containing incorrect information.

This rulemaking action was not reviewed under Executive Order 12886. Further, NHTSA has determined that the action is not significant under Department of Transportation regulatory policies and procedures. Based on the level of the fees and the volume of affected vehicles, NHTSA currently anticipates that the costs of the final rule are so minimal as not to warrant preparation of a full regulatory evaluation. The action does not involve any substantial public interest or controversy. There will be no substantial effect upon State and local governments. There will be no substantial impact upon a major transportation safety program. Both the number of registered importers and determinations are estimated to be comparatively small. A regulatory evaluation analyzing the economic impact of the final rule adopted on September 29, 1989, was prepared, and is available for review in the docket.

B. Regulatory Flexibility Act

The agency has also considered the effects of this action in relation to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). I certify that this action will not have a substantial economic impact upon a substantial number of small entities.

The following is NHTSA's statement providing the factual basis for the certification (5 U.S.C. 605(b)). The amendment would primarily affect entities that currently modify nonconforming vehicles and which are small businesses within the meaning of the Regulatory Flexibility Act; however, the agency has no reason to believe that a substantial number of these companies cannot pay the fees proposed by this action which are only modestly increased (and in some instances decreased) from those now being paid by these entities, and which can be recouped through their customers. The cost to owners or purchasers of altering nonconforming vehicles to conform with the FMVSS may be expected to increase (or decrease) to the extent necessary to reimburse the registered importer for the fees payable to the agency for the cost of carrying out the registration program and making eligibility decisions, and to compensate Customs for its bond processing costs.

Governmental jurisdictions are not affected at all since they are generally neither importers nor purchasers of nonconforming motor vehicles.

C. Executive Order 13132 (Federalism)

Executive Order 13132 (64 FR 43255, August 10, 1999), revokes and replaces Executive Orders 12612 “Federalism” and 12875 “Enhancing the Intergovernmental Partnership.” E.O. 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” Executive Order 13132 defines the term “Policies that have federalism implications” to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, NHTSA may not issue a regulation that has federalism implication, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the proposed regulation.

The rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132. Thus, the requirements of section 6 of the Executive Order do not apply to this rulemaking action.

D. National Environmental Policy Act

NHTSA has analyzed this action for purposes of the National Environmental Policy Act. The action will not have a significant effect upon the environment because it is anticipated that the annual volume of motor vehicles imported through registered importers will not vary significantly from that existing before promulgation of the rule.

E. Civil Justice

This proposed rule does not have a retroactive or preemptive effect. Judicial review of a rule based on this proposal may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.

F. Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the cost, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because the final rule based will not have an effect of $100 million, no Unfunded Mandates assessment has been prepared.

List of Subjects in 49 CFR Part 594

Imports, Motor vehicle safety, Motor vehicles.

PART 594—[AMENDED] In consideration of the foregoing, 49 CFR part 594 is amended as follows: 1. The authority citation for part 594 reads as follows: Authority:

c. Removing the year “1998” in paragraph (d) and adding in its place “2000,”

d. Revising the final sentence of paragraph (h); and

e. Revising paragraph (i) to read as follows:

§ 594.6 Annual fee for administration of the registration program.

(a) Each person filing an application to be granted the status of a Registered Importer pursuant to part 592 of this chapter on or after October 1, 2000, must pay an annual fee of $584, as calculated below, based upon the direct and indirect costs attributable to:

(b) That portion of the initial annual fee attributable to the processing of the application for applications filed on and after October 1, 2000, is $345. The sum of $345, representing this portion, shall not be refundable if the application is denied or withdrawn.

(h) * * * This cost is $13.90 per man-hour for the period beginning October 1, 2000.

(i) Based upon the elements, and indirect costs of paragraphs (f), (g), and (h) of this section, the component of the initial annual fee attributable to administration of the registration program, covering the period beginning October 1, 2000, is $239. When added to the costs of registration of $345, as set forth in paragraph (b) of this section, the costs per applicant to be recovered through the annual fee are $584. The annual renewal registration fee for the period beginning October 1, 2000, is $416.

3. Section 594.7 is amended by revising paragraph (e) to read as follows: § 594.7 Fee for filing petitions for a determination whether a vehicle is eligible for importation.

(e) For petitions filed on and after October 1, 2000, the fee payable for seeking a determination under paragraph (a)(1) of this section is $175. The fee payable for a petition seeking a determination under paragraph (a)(2) of this section is $800. If the petitioner requests an inspection of a vehicle, the sum of $550 shall be added to such fee. No portion of this fee is refundable if the petition is withdrawn or denied.

4. Section 594.8 is amended by revising the first sentence of paragraph (c) to read as follows:

§ 594.8 Fee for importing a vehicle pursuant to a determination by the Administrator.

(c) If a determination has been made on or after October 1, 2000, pursuant to the Administrator's initiative, the fee for each vehicle is $125. * * *

5. Section 594.9 is amended by revising paragraph (c) to read as follows:

§ 594.9 Fee for reimbursement of bond processing costs.

(c) The bond processing fee for each vehicle imported on and after October 1, 2000, for which a certificate of conformity is furnished, is $5.75.

6. Section 594.10 is amended by adding two new sentences to the end of paragraph (d) to read as follows:

§ 594.10 Fee for review and processing of conformity certificate.

(d) * * * However, if the vehicle covered by the certificate has been entered electronically with the U.S. Customs Service through the Automated Broker Interface and the registered importer submitting the certificate has an e-mail address, the fee for the certificate is $6, provided that the fee is paid by a credit card issued to the registered importer. If NHTSA finds that the information in the entry or the certificate is incorrect, requiring further processing, the processing fee shall be $16.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Emergency interim rule; request for comments.

SUMMARY:

This emergency interim rule prohibits the use of trap gear in the royal red shrimp fishery within the exclusive economic zone (EEZ) of the Gulf of Mexico. The intended effect of this emergency interim rule is to prevent gear conflict and overfishing in the royal red shrimp fishery.

DATES:

This emergency interim rule is effective September 14, 2000, through March 18, 2001. Comments must be received no later than 4:30 p.m., eastern standard time, on October 19, 2000.

ADDRESSES:

Written comments on this emergency interim rule must be mailed to, and copies of documents supporting this action may be obtained from, the Southeast Regional Office, NMFS, 9721 Executive Center Drive N., St. Petersburg, FL 33702. Comments also may be submitted via fax to 727-570-5583. Comments will not be accepted if submitted via e-mail or Internet. Comments on ambiguity or unnecessary complexity arising from the language used in this emergency interim rule should be directed to the Southeast Regional Office at the address given here.

The shrimp fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Shrimp Fishery of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council (Council) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

Background

On January 27, 1999, NMFS published a final rule (64 FR 4030) pursuant to section 305(a) of the Magnuson-Stevens Act, establishing a list of authorized fisheries and fishing gear and notification guidelines for actions to be taken by regional fishery management councils (councils) and NMFS upon receipt of a notification of the intent to fish or use a fishing gear that is not on that authorized list. The list of fisheries and gear was revised upon publication of a revised final rule effective December 1, 1999 (64 FR 67511, December 2, 1999). Under the final rule, no person or vessel may employ fishing gear or engage in a fishery not included on the list without giving 90-day advance written notice to the appropriate council.

Upon receipt of a notification of intent to participate in an unlisted fishery or use an unlisted fishing gear, a council must immediately begin consideration of the notification. If the council finds that the use of an unlisted gear or participation in an unlisted fishery would not compromise the effectiveness of conservation and management efforts, it shall recommend that NMFS amend the list of authorized fisheries and gear. If the council finds that the proposed gear or fishery will be detrimental to conservation and management efforts, it will recommend that NMFS not amend the authorized list of fisheries and gear. Instead, it will request NMFS to publish emergency or interim regulations specifically to prohibit the use of the proposed gear, and begin preparation of an amendment to the subject fishery management plan, if appropriate. Ninety days after the receipt by the Council of a notification, the individual may use the gear unless regulatory action is taken to prohibit the use of the gear.

Royal red shrimp have been a small component of the Gulf of Mexico shrimp fishery since the early 1960s. The fishery uses modified penaeid shrimp trawls at depths exceeding 100 fathoms (183 meters). Trap gear is not an authorized gear in this fishery under the provisions of the FMP. On June 16, 2000, a fisherman notified the Council of his intent to use trap gear to fish for royal red shrimp in the EEZ of the Gulf of Mexico. At its July 10-13, 2000, meeting, the Council considered the notification, and based on the information available, the Council determined that allowing trap gear in the royal red shrimp fishery posed a threat to ongoing conservation and management efforts because of a potential for gear conflicts with the existing trawl fishery.

Criteria For Issuing An Emergency Rule

NMFS policy guidelines for the use of emergency rules (62 FR 44421, August 21, 1997), require that an emergency situation results from recent, unforeseen events, or recently discovered circumstances; presents a serious management problem; and realizes immediate benefits from the emergency rule that outweigh the value of prior notice, opportunity for public comment, and deliberative consideration expected under the normal rulemaking process. Compliance with the NMFS policy guidelines is discussed here.

Recent, Unforeseen Events or Recently Discovered Circumstances

Based on its review of the June 16, 2000, notification to use trap gear in the royal red shrimp fishery, the Council voted to add options to its draft FMP Amendment 11 to prohibit the use of this gear in the subject fishery. Amendment 11 is scheduled for completion in November 2000; must be reviewed by NMFS; and, if approved, likely would not be implemented prior to April 2001. Therefore, to avoid management problems in the fishery, as identified by the Council, a prohibition on the use of trap gear must be implemented on or before September 14, 2000 (the date 90 days after receipt by the Council of notification of intent to use unauthorized gear). Consequently, the Council voted without objection to request NMFS to promulgate regulations to prohibit the use of trap gear in the royal red shrimp fishery within the EEZ of the Gulf of Mexico.

Serious Management Problems in the Fishery

The intended effect of this emergency interim rule is to prevent gear conflict that could compromise vessel safety, and to prevent overfishing in the royal red shrimp fishery. Gear conflicts are likely to occur between the traditional trawl fishery and the proposed trap line fishery on the royal red shrimp fishing grounds. This could result in substantial damage and loss of fishing gears and an increase in cost for participants in the fishery, as well as vessel safety issues because of the depth of the fishing effort, the weight of the deployed gears, and the fact that the fishing grounds are far offshore. Additionally, the introduction of new fishing effort could result in landings exceeding maximum sustainable yield (MSY), thus overfishing the resource. Since 1993, landings from the traditional trawl fishery have ranged from 200,000 to 335,000 lb (90,719 to 151,953 kg), which is approaching the MSY of 392,000 lb (177,808 kg) for the fishery.

Immediate Benefits

Prohibiting the use of trap gear in the royal red shrimp fishery is anticipated to avoid economic impacts from gear damage and loss from gear conflicts in the fishery, and maintain harvest within the MSY threshold, thus, preventing overfishing. Should landings exceed MSY, and overfishing occur, additional actions would be necessary to reduce the allowable catch for either or both gear types in the fishery. The Council concluded, and NMFS agrees, that a restriction on the landings by the traditional trawl fishery to accommodate a non-traditional fishery would be inappropriate, particularly given that the trap fishery also would result in serious gear conflicts, most likely jeopardizing the ability to obtain optimum yield from the fishery.

Period of Effectiveness

This emergency interim rule is being made effective for 180 days, as authorized by section 305(c) of the Magnuson-Stevens Act. It may be extended for up to an additional 180 days, provided that the public has had an opportunity to comment on it and the Council is actively preparing an FMP amendment to address the emergency on a permanent basis. Public comments on this emergency interim rule and the Council's actions will be considered in determining whether to extend this emergency interim rule.

Classification

The Assistant Administrator for Fisheries, NOAA (AA), has determined that this emergency interim rule is necessary to prevent gear conflict and overfishing in the royal red shrimp fishery. The AA has also determined that this rule is consistent with the Magnuson-Stevens Act and other applicable laws.

This emergency interim rule has been determined to be not significant for purposes of Executive Order 12866.

NMFS has assessed the regulatory impacts associated with this emergency interim rule.

Currently, trap gear is not on the list of authorized fishing gear (50 CFR 600.725) for the royal red shrimp fishery in the Gulf of Mexico and, therefore, is not allowed. However, consistent with the guidelines contained in 50 CFR 600.725, an individual fisherman may notify the Council of the intent to use a gear not on the list. Ninety days after such notification, the individual may use the gear unless regulatory action is taken to prohibit the use of the gear. The Council was notified on June 16, 2000, of intent to use trap gear in the royal red fishery. This emergency interim rule is designed to maintain the status quo until such time as the Council can prepare and submit to NMFS for review and approval an FMP amendment to prohibit the gear. Because the emergency interim rule is designed to prohibit the use of trap gear in the royal red shrimp fishery, namely the status quo, there are no expected economic consequences to the participants in the fishery.

If the use of trap gear in the royal red shrimp fishery in the EEZ of the Gulf of Mexico were not prohibited by September 14, 2000, the Council concluded, as explained in the SUPPLEMENTARY INFORMATION, that serious gear conflict, economic losses to fishery participants, and overfishing could occur. Accordingly, under authority set forth at 5 U.S.C. 553(b)(B), the AA finds that providing notice and the opportunity for prior public comment would be contrary to the public interest. Because it would delay the completion of regulatory action to prohibit the use of trap gear in the royal red shrimp fishery in the EEZ of the Gulf of Mexico beyond September 14, 2000. For this same reason, under 5 U.S.C. 553(d)(3), the AA finds for good cause that a delay in the effective date of this emergency interim rule would be contrary to the public interest because this emergency interim rule does not impose new or additional restrictions; rather, it maintains the status quo condition regarding allowable gear in the royal red shrimp fishery, i.e., trap gear is not allowed, no time is required to come into compliance with the rule. For this reason, under 5 U.S.C. 553(d)(3), the AA also finds good cause that a delay in the effective date of this emergency interim rule is unnecessary.

Because prior notice and an opportunity for public comment are not required to be provided for this emergency interim rule by 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable.

The President has directed Federal agencies to use plain language in their communications with the public, including regulations. To comply with this directive, we seek public comment on any ambiguity or unnecessary complexity arising from the language used in this emergency interim rule. Such comments should be sent to NMFS Southeast Regional Office (see ADDRESSES).

Dated: September 13, 2000.Bruce C. Morehead,Acting Assistant Administrator for Fisheries, National Marine Fisheries Service.For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:PART 622—FISHERIES OF THE CARIBBEAN, GULF, AND SOUTH ATLANTIC

1. The authority citation for part 622 continues to read as follows:

Authority:

16 U.S.C. 1801 et seq.

2. In § 622.31, paragraph (k) is added to read as follows:§ 622.31Prohibited gear and methods.

(k) Traps for royal red shrimp in the Gulf EEZ. A trap may not be used to fish for royal red shrimp in the Gulf EEZ. A trap used to fish for royal red shrimp in the Gulf EEZ may be disposed of in any appropriate manner by the Assistant Administrator or an authorized officer.

National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

ACTION:

Final 2000 harvest specifications; technical amendment; correction.

SUMMARY:

This document corrects Table 7 of the technical amendment to the final 2000 prohibited species catch (PSC) allowances specified for trawl groundfish fisheries of the Bering Sea and Aleutian Islands (BSAI).

DATES:

Effective June 15, 2000, through 2400 hrs A.l.t. December 31, 2000.

FOR FURTHER INFORMATION CONTACT:

Andrew N. Smoker, 907-586-7228.

SUPPLEMENTARY INFORMATION:

This document contains corrections to the technical amendment to the final 2000 PSC allowances specified for trawl groundfish fisheries of the BSAI.

In the technical amendment, Fisheries of the Exclusive Economic Zone Off Alaska; Prohibited Species Catch in the Bering Sea and Aleutian Islands, published on July 10, 2000 (65 FR 42302), FR Doc. 00-17269, corrections are made as follows:

1. In the document, 2000 harvest specifications; technical amendment, published on July 10, 2000 (65 FR 42302), FR Doc. 00-17269, on page 42303, mathematical errors were made in Table 7. Table 7 is corrected to read as follows:

Table 7 to Part 679 [Corrected]

In the second column, under the heading, “Halibut mortality (mt) BSAI,” the sixth entry, “7457” that corresponds with “Jan. 1-April 30,” is corrected to read “457” and in the last line “4,675” that corresponds with the “Grand Total” is corrected to read “4,576”.

The Food Safety and Inspection Service (FSIS) proposes to add regulations concerning sharing recall information with State and other Federal government agencies. This proposed rule would permit FSIS to disclose to officials of State governments certain proprietary information without being compelled to disclose the information to the public under the Freedom of Information Act (FOIA). Also, the proposed rule would advise the public that FSIS will share proprietary information with other Federal agencies. Specifically, this proposal addresses situations where, during a recall activity, it is beneficial for FSIS to share certain proprietary information from a firm with State and other Federal government agencies. This action is necessary to facilitate cooperation in regulatory activities and will contribute to improved public health protection.

DATES:

Submit comments on or before November 20, 2000.

ADDRESSES:

Submit one original and two copies of written comments to FSIS Docket Clerk, Docket #99-029P, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. All comments submitted in response to this proposal will be available for public inspection in the Docket Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday through Friday.

SUPPLEMENTARY INFORMATION:Background Overview of Recalls of Meat and Poultry Products

FSIS is responsible for ensuring that meat and poultry products are safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), which require Federal inspection and regulation of meat and poultry products prepared for distribution in commerce for use as human food. When meat or poultry products in commerce are found to present an actual or potential health hazard to consumers, or otherwise to violate the provisions of the FMIA or PPIA, FSIS will request that firms recall the suspect products.

Recalls are voluntary actions taken by manufacturers or distributors in cooperation with Federal and State agencies. A product is recalled when found to be adulterated or misbranded under provisions of the FMIA or PPIA. Although the product is marked, inspected and passed, FSIS may determine, based on information that has become available to the Agency, the product is no longer eligible to bear the mark of inspection.

FSIS does not have statutory authority to order recalls. Recall actions are initiated by a firm, either on its own initiative or at the request of FSIS. If a firm does not agree to initiate a recall, FSIS has authority to detain and seize the product once it is located. A recall may be undertaken by a firm that manufactures, wholesales, or distributes meat or poultry products. Retail establishments are exempt from inspection. However, when meat or poultry products are manufactured at retail establishments and found to be adulterated, FSIS expects the retail establishment to recall the product. FSIS will coordinate with State agencies to accomplish the recall. Firms can be large corporations, partnerships, or family owned businesses.

When firms conduct recalls, the Recall Management Division (RMD) of FSIS classifies the health risk associated with the recalled products. A Class I recall involves a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death. Class II recalls involve a potential health hazard situation where there is a remote probability of adverse health consequences from the use of the product. Class III recalls involve a situation where the use of the product will not cause adverse health consequences. RMD also recommends the scope (the amount and kind of product recalled) of the recall, distributes recall notification reports to public health officials, and assists FSIS' Office of Congressional and Public Affairs in notifying the public through press releases. Information on all recalls is posted on the FSIS web site, www.fsis.usda.gov. FSIS' Office of Field Operations, compliance personnel verify that firms conduct voluntary recalls and evaluate their effectiveness through checks performed in the field.

Changes in Recall Policy and New Recall Directive

Over the last few years, firms have initiated several major Class I recalls at FSIS' request, one of which involved over 25 million pounds of product believed to be contaminated with E. coli O157:H7. In November 1997, FSIS created a Recall Working Group to assess the adequacy of its current recall policies and practices. Based on a full review of issues presented to it, the Recall Working Group determined that the Agency's recall policies and procedures are basically sound; however, the Working Group believed that some improvements could be made in the recall process.

Based on its careful consideration of that report and the comments on it, and in consultation with the Secretary of Agriculture and the Under Secretary for Food Safety, FSIS issued on January 19, 2000 a new version of FSIS Directive 8080.1 (Revision 3), “Recall of Meat and Poultry Products” and issued a Guide (as an amendment to the new Directive), “Product Recall Guidelines for Establishments.” The main purpose of the Directive is to update the Agency's procedures and to set out two new policies. First, FSIS has begun issuing press releases for all meat and poultry recalls. The press releases are drafted to reflect the health risk presented by the product being recalled, and how the product is identifiable to consumers and users.

Second, the Directive defines the circumstances in which FSIS will consider a recall to be completed. The Agency states that it will consider a recall to be complete when the recalling firm has made all reasonable efforts to recover the product, and it either has disposed of the product or has it under control. FSIS addressed this concern in response to complaints that some recalls remained open for months and even years.

The Guide outlines the actions that a firm should take in anticipation of a recall and in the event that the plant decides to recall product. The Guide states that a firm should prepare and maintain a detailed, written recall plan. It further states that this plan should describe, on a step-by-step basis, the procedure that the firm will follow when recalling a product.

Changes in Recall Policy and Sharing Recall Information With State and Federal Agencies

This proposed rule is intended to facilitate the sharing of certain proprietary (non-public) information (e.g., distribution lists) with State and other Federal government agencies in order to enhance cooperation in recall activities, contribute to improved public health protection, and maintain effective communication with these agencies. FSIS has modeled this proposed rule, in part, on two Food and Drug Administration (FDA) regulations, 21 CFR 20.85 and 20.88, that permit FDA to disclose certain proprietary information to State governments and other Federal officials without requiring FDA to make the information or documents available to the public.

Historically, FSIS' communications with State agencies generally had the same status as communication with any member of the public. In accordance with 5 U.S.C. 552(a)(3)(A), any record of the Agency that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public.

There are times when public disclosure of information will undermine legitimate private rights and government responsibilities. In drafting the FOIA (5 U.S.C. 552), Congress recognized the need for the Federal government to be able to withhold certain categories of information from public disclosure. Examples of such categories of records relevant to FSIS include:

FSIS works closely with Federal and State agencies in situations involving outbreaks of foodborne illness and the recall of meat and poultry products to protect the public health. To enhance cooperation with State and other Federal government agencies, FSIS needs the ability, in certain circumstances, to disclose confidential commercial information to other agencies.

Therefore, FSIS is proposing to amend 9 CFR part 390 by adding a new section that will enable FSIS to share with other State agencies non-public information that is protected from mandatory public disclosure by exemption 4 of the FOIA (5 U.S.C. 552(b)(4)). Exemption 4 covers two broad categories of information in Federal agency records—trade secret information and information that is: (1) commercial or financial, (2) obtained from a person, and (3) privileged or confidential (”confidential commercial information”). The new section also addresses sharing of information with other Federal agencies which is not limited by FOIA, but is included in the proposed rule to clearly advise persons that information will be shared with other Federal agencies.

The Agency is proposing to provide that the Administrator or designee may disclose confidential commercial information submitted to FSIS to State and other Federal government agencies as part of a cooperative effort between agencies, provided that:

The State government officials have provided a written statement establishing authority to protect confidential commercial information from public disclosure and a written commitment not to disclose such information without the submitter's written permission or written confirmation from FSIS that the information is no longer confidential. Federal agencies must provide a written commitment not to disclose the information, but to refer the confidential commercial information to FSIS in order for FSIS to respond to the request for information.

FSIS intends that the disclosure of information to other agencies will be for the purpose of recalls of meat and poultry products. The regulatory text of this proposed rule limits the sharing of information to recalls.

The proposed amendment to 9 CFR part 390 would establish that the above government officials are not members of the public for purposes of disclosure of confidential commercial information submitted to FSIS, and that such disclosures would not invoke the requirements in 9 CFR part 390 of uniform access to records. Disclosure of confidential commercial information to government agencies as specified in the proposed amendment would be an “authorized” disclosure.

FSIS believes this proposed rule will do nothing to diminish current public access to Agency records. The purpose of this proposed rule is not to reduce the number or types of records that will be available to the public from FSIS but to enhance the Agency's ability to engage in information exchanges.

Also, this proposed regulation is related to a Memorandum of Understanding (MOU) between FSIS and the Food and Drug Administration (FDA) signed in February 1999 that facilitates sharing of information. This MOU is limited in effect by FSIS' inability to provide proprietary information on recalls to FDA or other affected authorities. This regulation would remedy this limitation of the MOU.

Compliance With Executive Order 12866 and the Regulatory Flexibility Act of 1996

This rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

The Administrator, FSIS, has determined that this action will not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act (5 U.S.C. 601) because this rule promotes cooperation among FSIS, other Federal and State agencies.

This proposed action is new. No significant changes in recall activities are expected as a result of this action.

1. Net benefits are likely to be increased public health protection.

2. Net benefits are likely to be enhanced communications and cooperation between FSIS and State and other Federal agencies.

Expected Benefits

During a meat or poultry recall, FSIS will be able to share sensitive, confidential proprietary information with State agencies and other Federal agencies without having to disclose this information to the general public or media under the Freedom of Information Act. This will enable FSIS staff to verify that adulterated, un-healthful, or misbranded products are removed from consumer channels quickly and efficiently and to protect the public health.

Because of the proposed rule, the sharing of recall information will help all the government agencies work aggressively together to find solutions that will enhance public health and provide consumer protection from foodborne illnesses. The State agencies will provide a written agreement not to disclose such information without the submitter's written permission or written confirmation from FSIS. Federal agencies must agree not to release the information but to refer the information to FSIS for a response to the requestor. This will ensure that the other government agencies do not inadvertently share this information with the public. Increased consumer protection and public health, and efficiency in government are the basic benefits of this proposed rule.

Expected Costs

There are minimal costs associated with sharing recall information with State and other Federal agencies. Costs will consist of the labor it takes to draft and agree to Memorandum of Understandings, and the labor it takes to share the information with these agencies, but these costs are already absorbed by the labor cost of these officials. There are no costs to industry.

Expected Effects on Small Entities

No disproportionate significant economic impact will be experienced by small entities. FSIS will share with States and other Federal officials confidential and proprietary information of both large and small entities, if the recall warrants it.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this proposed rule, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at (202) 720-5704.

Executive Order 12898

Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,” FSIS has considered potential impacts of this proposed rule on environmental and health conditions in low-income and minority communities.

Sharing recall information with other agencies will benefit FSIS, the regulated industry and consumers. Thus, this proposed regulation does not adversely affect the public health or environment in low-income and minority communities.

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule. However, the administrative procedures specified in 9 CFR 390.7 must be exhausted prior to any judicial challenge of the application of the provisions of this proposed rule, if the challenge involves any decision of an FSIS employee relating to a denial of access of information.

Paperwork Requirements

There are no paperwork or recordkeeping requirements associated with this proposed rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

List of Subjects in 9 CFR Part 390

Confidential business information, Freedom of information, Government employees.

For the reasons set forth in the preamble, FSIS proposes to amend 9 CFR part 390 as follows:

1. The heading of 9 CFR part 390 is revised to read as follows:

PART 390—FREEDOM OF INFORMATION AND PUBLIC INFORMATION

2. The authority citation for part 390 continues to read as follows:

Authority:

5 U.S.C. 301, 552; 7 CFR 1.3, 2.7.

3. Section 390.9 is added to read as follows:

§ 390.9 Communications with State and other Federal government agencies.

(a) The Administrator of the Food Safety and Inspection Service (FSIS) or designee, may authorize the disclosure of confidential commercial information submitted to FSIS, or incorporated into agency-prepared records, to State and other Federal government agencies as part of a recall of meat or poultry products, provided that:

(1) The State agency has provided both a written statement establishing its authority to protect confidential commercial information from public disclosure and a written commitment not to disclose any such information provided by FSIS without the written permission of the submitter of the information or written confirmation by FSIS that the information no longer has confidential status. Federal government agencies must provide a written commitment not to disclose the information, but to refer the confidential commercial information to FSIS in order for FSIS to respond to the request for information; and

(2) The Administrator of FSIS or designee determines that disclosure would be in the interest of public health.

(b) This provision does not authorize the disclosure to State or other Federal government agencies of trade secret information, unless otherwise provided by law or pursuant to an express written authorization provided by the submitter of the information.

(c) Information disclosed under this section is not a disclosure of information to the public. Disclosures made under this section do not waive any FOIA exemption protection.

This document proposes the adoption of a new airworthiness directive (AD) that is applicable to all British Aerospace Model BAC 1-11 401/AK and 410/AQ airplanes. This proposal would require replacement of certain landing gear brake accumulators with improved accumulators. This action is necessary to prevent loss of hydraulic pressure and possible structural damage to the airplane due to failure of the accumulator. This action is intended to address the identified unsafe condition.

DATES:

Comments must be received by October 19, 2000.

ADDRESSES:

Submit comments in triplicate to the Federal Aviation Administration (FAA), Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2000-NM-113-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056. Comments may be inspected at this location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal holidays. Comments may be submitted via fax to (425) 227-1232. Comments may also be sent via the Internet using the following address: 9-anm-nprmcomment@faa.gov. Comments sent via fax or the Internet must contain “Docket No. 2000-NM-113-AD” in the subject line and need not be submitted in triplicate. Comments sent via the Internet as attached electronic files must be formatted in Microsoft Word 97 for Windows or ASCII text.

The service information referenced in the proposed rule may be obtained from British Aerospace, Service Support, Airbus Limited, P.O. Box 77, Bristol BS99 7AR, England. This information may be examined at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington.

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this notice may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-113-AD.” The postcard will be date stamped and returned to the commenter.

The Civil Aviation Authority (CAA), which is the airworthiness authority for the United Kingdom, notified the FAA that an unsafe condition may exist on all British Aerospace Model BAC 1-11 401/AK and 410/AQ airplanes. The CAA advises that corrosion has been found on the steel shell under the nameplate and in the threads beneath the end caps of certain landing gear brake accumulators. These accumulators had exceeded their original calendar life. Additionally, fatigue and stress corrosion may have weakened the end caps of the accumulator. Failure of the accumulator, if not corrected, could result in loss of hydraulic pressure and possible structural damage to the airplane.

Explanation of Relevant Service Information

British Aerospace has issued Service Bulletin 32-PM6054, dated February 2000, which describes procedures for replacement of certain landing gear brake accumulators with accumulators that are fitted with end caps made from stress and corrosion resistant aluminum alloy. The improved accumulators also have increased wall thickness in the end caps, a higher strength shell, and corrosion prevention measures in the threads and under the nameplate and mounting straps. The service bulletin references Parker Service Bulletin 1356-653562-32-100, dated September 23, 1999, as an additional source of service information for accomplishment of the replacement.

Accomplishment of the actions specified in the British Aerospace service bulletin is intended to adequately address the identified unsafe condition. The CAA classified this service bulletin as mandatory in order to ensure the continued airworthiness of these airplanes in the United Kingdom.

FAA's Conclusions

This airplane model is manufactured in the United Kingdom and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the CAA has kept the FAA informed of the situation described above. The FAA has examined the findings of the CAA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Explanation of Requirements of Proposed Rule

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the British Aerospace service bulletin described previously.

Cost Impact

The FAA estimates that 13 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 1 work hour per airplane to accomplish the proposed actions, and that the average labor rate is $60 per work hour. Required parts would cost approximately $9,940 per airplane. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $130,000, or $10,000 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

Regulatory Impact

The regulations proposed herein would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this proposed regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39—AIRWORTHINESS DIRECTIVES

1. The authority citation for part 39 continues to read as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by adding the following new airworthiness directive:

Applicability: All Model BAC 1-11 401/AK and 410/AQ airplanes, certificated in any category.

Note 1:

This AD applies to each airplane identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (c) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.

Compliance: Required as indicated, unless accomplished previously.

To prevent loss of hydraulic pressure and possible structural damage to the airplane due to failure of the landing gear brake accumulator, accomplish the following:

Replacement

(a) Within 10 months after the effective date of this AD, replace any Parker landing gear brake accumulator having part number (P/N) 1356-653562 with an accumulator having P/N 1356-653562M2, in accordance with British Aerospace Service Bulletin 32-PM6054, dated February 2000.

Note 2:

The British Aerospace service bulletin references Parker Service Bulletin 1356-653562-32-100, dated September 23, 1999, as an additional source of service information for accomplishment of the replacement.

Spares

(b) As of the effective date of this AD, no Parker landing gear brake accumulator having P/N 1356-653562 shall be installed on any airplane.

Alternative Methods of Compliance

(c) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, International Branch, ANM-116.

Note 3:

Information concerning the existence of approved alternative methods of compliance with this AD, if any, may be obtained from the International Branch, ANM-116.

Special Flight Permits

(d) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.

This document proposes the adoption of a new airworthiness directive (AD) that is applicable to certain Saab Model SAAB SF340A and SAAB 340B series airplanes. This proposal would require inspecting the connector on the refuel/defuel panel and the electrical connector on the illuminated placard to detect signs of fluid ingression or corrosion, and corrective actions. This action is necessary to prevent electrical shorts or arcing at the illuminated placard connector at the refuel/defuel panel, which could result in a potential ignition source for fuel vapors during fueling procedures. This action is intended to address the identified unsafe condition.

DATES:

Comments must be received by October 19, 2000.

ADDRESSES:

Submit comments in triplicate to the Federal Aviation Administration (FAA), Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2000-NM-213-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056. Comments may be inspected at this location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal holidays. Comments may be submitted via fax to (425) 227-1232. Comments may also be sent via the Internet using the following address: 9-anm-nprmcomment@faa.gov. Comments sent via fax or the Internet must contain “Docket No. 2000-NM-213-AD” in the subject line and need not be submitted in triplicate. Comments sent via the Internet as attached electronic files must be formatted in Microsoft Word 97 for Windows or ASCII text.

The service information referenced in the proposed rule may be obtained from Saab Aircraft AB, SAAB Aircraft Product Support, S-581.88, Linköping, Sweden. This information may be examined at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington.

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this notice may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-213-AD.” The postcard will be date stamped and returned to the commenter.

The Luftfartsverket (LFV), which is the airworthiness authority for Sweden, notified the FAA that an unsafe condition may exist on certain Saab Model SAAB SF340A and SAAB 340B series airplanes. The LFV advises that electrical shorts and arcing can occur at the illuminated placard connector at the wing refuel/defuel panel on these airplanes. These electrical shorts are caused by fluid entering through the mounting hole to the unsealed illuminated placard connector. The illuminated placard is supplied with 28VDC power only when the refuel/defuel panel switch is selected to ON when the aircraft is on the ground during refueling or defueling. Electrical shorts or arcing at the illuminated placard connector at the refuel/defuel panel could result in a potential ignition source for fuel vapors during fueling procedures.

Explanation of Relevant Service Information

Saab has issued Service Bulletin 340-28-022, dated February 25, 2000, which describes procedures for inspecting the electrical connector on the refuel/defuel panel and the electrical connector on the illuminated placard to detect signs of fluid ingression or corrosion, and corrective actions. The corrective actions involve accomplishing a sealing procedure, or a cleaning/sealing procedure, as applicable; and repair of corrosion on the refuel/defuel panel mounting plate. Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition. The LFV classified this service bulletin as mandatory and issued Swedish airworthiness directive 1-156, dated February 28, 2000, in order to assure the continued airworthiness of these airplanes in Sweden.

FAA's Conclusions

These airplane models are manufactured in Sweden and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the LFV has kept the FAA informed of the situation described above. The FAA has examined the findings of the LFV, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Explanation of Requirements of Proposed Rule

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the service bulletin described previously.

Cost Impact

The FAA estimates that 289 Model SAAB SF340A and SAAB 340B series airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 4 work hours per airplane to accomplish the proposed actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $69,360, or $240 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

Regulatory Impact

The regulations proposed herein would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this proposed regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39—AIRWORTHINESS DIRECTIVES

1. The authority citation for part 39 continues to read as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by adding the following new airworthiness directive:

SAAB Aircraft AB: Docket 2000-NM-213-AD.

Applicability: Model SAAB SF340A series airplanes, serial numbers -004 through -159 inclusive; and Model SAAB 340B series airplanes, serial numbers -160 through -459 inclusive; certificated in any category; on which a refuel/defuel panel having part number 7239160-505 is installed.

Note 1:

This AD applies to each airplane identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (b) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.

Compliance: Required as indicated, unless accomplished previously.

To prevent electrical shorts or arcing at the illuminated panel connector at the refuel/defuel panel, which could result in a potential ignition source for fuel vapors during fueling procedures, accomplish the following:

Inspection and Corrective Actions

(a) Within 6 months after the effective date of this AD, inspect the electrical connector on the refuel/defuel panel and the electrical connector on the illuminated placard to detect signs of fluid ingression or corrosion; and accomplish applicable corrective actions (including a sealing procedure, a cleaning/sealing procedure, and repair of corrosion on the refuel/defuel panel mounting plate); in accordance with Saab Service Bulletin 340-28-022, dated February 25, 2000.

Alternative Methods of Compliance

(b) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, International Branch, ANM-116.

Note 2:

Information concerning the existence of approved alternative methods of compliance with this AD, if any, may be obtained from the International Branch, ANM-116.

Special Flight Permits

(c) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.

Note 3:

The subject of this AD is addressed in Swedish airworthiness directive 1-156, dated February 28, 2000.

This document proposes the adoption of a new airworthiness directive (AD) that is applicable to all Fokker Model F.28 Mark 1000, 2000, 3000, and 4000 series airplanes. This proposal would require a one-time general visual inspection for proper rigging of the liftdumper micro switches installed in the left- and right-hand sides of the pedestal; a functional check of the micro switches; and re-rigging the cam, if necessary. This action is necessary to detect and correct improper rigging of the liftdumper micro switches, which could result in inadvertent extension of the liftdumpers during takeoff roll. This action is intended to address the identified unsafe condition.

DATES:

Comments must be received by October 19, 2000.

ADDRESSES:

Submit comments in triplicate to the Federal Aviation Administration (FAA), Transport Airplane Directorate, ANM-114, Attention: Rules Docket No. 2000-NM-293-AD, 1601 Lind Avenue, SW., Renton, Washington 98055-4056. Comments may be inspected at this location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except Federal holidays. Comments may be submitted via fax to (425) 227-1232. Comments may also be sent via the Internet using the following address: 9-anm-nprmcomment@faa.gov. Comments sent via fax or the Internet must contain “Docket No. 2000-NM-293-AD” in the subject line and need not be submitted in triplicate. Comments sent via the Internet as attached electronic files must be formatted in Microsoft Word 97 for Windows or ASCII text.

The service information referenced in the proposed rule may be obtained from Fokker Services B.V., P.O. Box 231, 2150 AE Nieuw-Vennep, the Netherlands. This information may be examined at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington.

Interested persons are invited to participate in the making of the proposed rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified above. All communications received on or before the closing date for comments, specified above, will be considered before taking action on the proposed rule. The proposals contained in this notice may be changed in light of the comments received.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the proposed rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report summarizing each FAA-public contact concerned with the substance of this proposal will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-293-AD.” The postcard will be date stamped and returned to the commenter.

The Rijksluchtvaartdienst (RLD), which is the airworthiness authority for the Netherlands, notified the FAA that an unsafe condition may exist on all Fokker Model F.28 Mark 1000, 2000, 3000, and 4000 series airplanes. The RLD advises that it received two reports of inadvertent liftdumper deployments during takeoff roll. In each case, the flight crew did not notice anything abnormal; however, the liftdumper deployment was noticed and reported by outside observers. Subsequent investigation revealed some minor irregularities, but failed to establish the exact cause.

Results of a special test program performed by Fokker Services B.V. revealed that, with the throttle levers in full forward position and the liftdumper system armed, the rollers of both 75 percent liftdumper micro switches ran off the end of the cam. This caused the liftdumpers to deploy when the (simulated) wheel speed exceeded 50 knots and to remain extended until liftoff. Under normal circumstances, when the throttle levers are moved beyond approximately 75 percent high pressure (HP) revolutions per minute (rpm), these cams activate the micro switches to prevent liftdumper extension.

Improper rigging of the liftdumper micro switches could result in inadvertent extension of the liftdumpers during takeoff roll.

Explanation of Relevant Service Information

Fokker Services B.V. has issued Fokker Service Bulletin F28/27-186, including Manual Change Notification MCNM F28-020, dated May 8, 2000. The service bulletin describes procedures for a one-time general visual inspection for proper rigging of the liftdumper micro switches installed in the left- and right-hand sides of the pedestal; a functional check of the micro switches; and re-rigging the cam, if necessary. The RLD classified this service bulletin as mandatory and issued Dutch airworthiness directive 2000-073, dated May 31, 2000, in order to assure the continued airworthiness of these airplanes in the Netherlands.

FAA's Conclusions

This airplane model is manufactured in the Netherlands and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the RLD has kept the FAA informed of the situation described above. The FAA has examined the findings of the RLD, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Explanation of Requirements of Proposed Rule

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, the proposed AD would require accomplishment of the actions specified in the service bulletin described previously.

Cost Impact

The FAA estimates that 23 airplanes of U.S. registry would be affected by this proposed AD, that it would take approximately 4 work hours per airplane to accomplish the proposed actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of the proposed AD on U.S. operators is estimated to be $5,520, or $240 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the proposed requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

Regulatory Impact

The regulations proposed herein would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this proposal would not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this proposed regulation (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) if promulgated, will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the draft regulatory evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39—AIRWORTHINESS DIRECTIVES

1. The authority citation for part 39 continues to read as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by adding the following new airworthiness directive:

Fokker Services B.V.: Docket 2000-NM-293-AD.

Applicability: All Model F.28 Mark 1000, 2000, 3000, and 4000 series airplanes, certificated in any category.

Note 1:

This AD applies to each airplane identified in the preceding applicability provision, regardless of whether it has been modified, altered, or repaired in the area subject to the requirements of this AD. For airplanes that have been modified, altered, or repaired so that the performance of the requirements of this AD is affected, the owner/operator must request approval for an alternative method of compliance in accordance with paragraph (b) of this AD. The request should include an assessment of the effect of the modification, alteration, or repair on the unsafe condition addressed by this AD; and, if the unsafe condition has not been eliminated, the request should include specific proposed actions to address it.

Compliance: Required as indicated, unless accomplished previously.

To detect and correct improper rigging of the liftdumper micro switches, which could result in inadvertent extension of the liftdumpers during takeoff roll, accomplish the following:

Inspection and Functional Check

(a) Within 2 months after the effective date of this AD: Perform a one-time general visual inspection for proper rigging of the liftdumper micro switches installed in the left-and right-hand sides of the pedestal; and a functional check of the micro switches; as specified in Fokker Service Bulletin F28/27-186, including Manual Change Notification MCNM F28-020, dated May 8, 2000. Perform the inspection and the check in accordance with the Accomplishment Instructions of the service bulletin. If the micro switches are not rigged within the specifications provided in the service bulletin, prior to further flight, re-rig the cam in accordance with the service bulletin.

Note 2:

For the purposes of this AD, a general visual inspection is defined as: “A visual examination of an interior or exterior area, installation, or assembly to detect obvious damage, failure, or irregularity. This level of inspection is made under normally available lighting conditions such as daylight, hangar lighting, flashlight, or drop-light, and may require removal or opening of access panels or doors. Stands, ladders, or platforms may be required to gain proximity to the area being checked.”

Alternative Methods of Compliance

(b) An alternative method of compliance or adjustment of the compliance time that provides an acceptable level of safety may be used if approved by the Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate. Operators shall submit their requests through an appropriate FAA Principal Maintenance Inspector, who may add comments and then send it to the Manager, International Branch, ANM-116.

Note 3:

Information concerning the existence of approved alternative methods of compliance with this AD, if any, may be obtained from the International Branch, ANM-116.

Special Flight Permits

(c) Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the requirements of this AD can be accomplished.

Note 4:

The subject of this AD is addressed in Dutch airworthiness directive 2000-073, dated May 31, 2000.

The Food and Drug Administration (FDA) is proposing to require that all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. The proposal reflects a growing concern in FDA and the medical community that overprescription and inappropriate use of systemic antibacterials has contributed to a dramatic increase in recent years in the prevalence of drug-resistant bacterial infections. The proposal is intended to encourage physicians to prescribe systemic antibacterials more judiciously and only when clinically necessary. The proposal is also intended to encourage physicians to counsel their patients about the proper use of such drugs and the importance of taking them exactly as directed.

DATES:

Submit written comments by December 4, 2000. See section III of this document for the proposed effective date of a final rule based on this document.

Antimicrobial resistance among disease-causing bacteria represents a serious and growing public health problem in the United States and worldwide. Many bacterial species, including the species that cause pneumonia and other respiratory tract infections, meningitis, and sexually transmitted diseases, are becoming increasingly resistant to the antimicrobial drugs used to treat them. Several bacterial species have developed strains that are resistant to every approved antimicrobial drug, thus severely limiting the therapeutic options available for adequate treatment.

Antimicrobial resistance in bacteria is not a new problem. For as long as antimicrobial drugs have been widely available—over 50 years now—bacteria have demonstrated an ability to develop resistance by a number of mechanisms, such as antibiotic-degrading enzymes. Over the past several years, however, the incidence of resistance in both hospital- and community-acquired infections has increased dramatically, making many common illnesses more difficult to treat than they were only 5 or 10 years ago.

The rise of resistance in the bacteriumStreptococcus pneumoniae provides a good example. S. pneumoniae is a common cause of middle-ear and sinus infections, as well as several life-threatening illnesses, including pneumonia, bacteremia, and meningitis. Strains of S. pneumoniae that are resistant to penicillin were observed as early as the 1960's. Over the following two or three decades, however, the frequency of drug-resistant S. pneumoniae strains remained relatively low. Even at the beginning of the 1990's, only about 5 percent of isolates showed decreased susceptibility to penicillin (Ref. 1). But in the past few years, that number has risen dramatically. In fact, in some parts of the country, up to 40 percent of all S. pneumoniae isolates are now intermediately or highly penicillin resistant (Ref. 2).

In the hospital setting, antimicrobial resistance is a particularly important problem. Each year in the United States, about 2 million patients acquire an infection while receiving treatment in a health care setting (Ref. 3). According to the Centers for Disease Control and Prevention (CDC), approximately 70 percent of those infections that are bacterial in nature are resistant to at least one of the antimicrobial drugs that have traditionally been used to treat them (Ref. 4).

A. Factors Contributing to the Emergence of Resistance

Several factors contribute to the increasing prevalence of antimicrobial resistance. One of the most important is the overuse or inappropriate use of antimicrobial drugs. The amount of overuse is difficult to establish with accuracy; however, several studies have provided estimates that provide a picture of substantial overuse of these products. Office-based physicians in the United States write more than 100 million antibiotic prescriptions each year. According to the CDC, however, as many as half of those prescriptions—a total of 50 million—are inappropriate, being prescribed for the common cold and other viral infections, including influenza, against which antibiotics are not active (Ref. 5). A recent study of paid Medicaid claims for treatment of respiratory tract infections in Kentucky found that 60 percent of adults received antibiotics to treat the common cold (Ref. 6). A survey of the prescribing patterns of office-based physicians in the United States in 1992 found that approximately 12 million antibiotic prescriptions, or 21 percent of all antibiotic prescriptions to adults, were written to treat colds, upper respiratory tract infections, and bronchitis, even though over 90 percent of these diseases are caused by viruses on which antibacterial drugs would have no effect (Ref. 7).

A 1995 congressional report estimated that 25 to 35 percent of hospital patients receive antibiotics either to prevent infections associated with surgery or to treat disease (Ref. 8). Another study found that from 1980 to 1992, per capita consumption of antibacterial drugs remained relatively constant, but the total volume increased from 86 million to 110 million prescriptions (Ref. 9). Moreover, the pattern of drug use changed over this period, with increased use of broad-spectrum antimicrobial drugs such as cephalosporins and decreased use of narrow-spectrum drugs such as penicillins.

Inappropriate antibiotic prescriptions can have serious consequences. Antimicrobial use increases the selective pressure on bacteria to develop and spread resistant strains. Thus, the more an antimicrobial is used, the more likely it is that bacteria will develop resistance to it.

Incomplete treatment with antibiotics also leads to more rapid selection of resistant organisms (Ref. 10). Even when physicians properly prescribe antibiotics, antibiotic resistance is promoted when patients skip doses or do not complete the entire course of therapy. This is because suboptimal therapy may allow more resistant organisms to survive and spread in the community. Therefore, educating patients about how to take antibiotics is a necessary step in reducing antibiotic resistance (Ref. 11). Patients also need to be educated that antibiotics should not be used to treat viral illnesses.

B. Responding to the Resistance Problem

Bacterial resistance can be reduced by decreasing the use of antibacterial drugs. For example, in response to increased erythromycin resistance of Group A streptococci, Finland implemented a nationwide campaign in 1992 to reduce the use of macrolide antibiotics (the class of which erythromycin is a member). Finnish consumption of this class of drug declined by about 43 percent in the first year and it has remained at a reduced level. By 1996, erythromycin-resistant Group A streptococci had declined in Finland by almost 48 percent (Ref. 12).

Important steps in decreasing the prevalence of antibacterial resistance and slowing its future development and spread are to educate physicians and the public about the problem of antibiotic resistance and to encourage more judicious use of antimicrobial drugs. FDA believes that professional labeling can be used to accomplish these objectives. Therefore, FDA is proposing to require that the labeling for systemic antibacterial drug products include certain statements about the inappropriate use of antimicrobials and the link between inappropriate use and the emergence of drug-resistant bacterial strains. Under the proposal, the labeling would include the following reminders for physicians:

• Antibacterial drugs should only be used in situations where a bacterial infection is either proven or strongly suspected.

• The type of bacteria involved in an illness and its antimicrobial susceptibility pattern should generally be identified before an antibacterial is chosen.

• The antibacterial chosen should be targeted for the specific organism to be eradicated rather than opting for a more broad-spectrum drug.

• Patients should be counseled about the proper use of antibacterials and the importance of taking them only as directed.

C. Scope of the Proposal

The focus of this proposed rule is systemic antibacterial drug products. Bacteria, however, are not the only microorganisms that can develop resistance to the drugs designed to treat them. Viruses, fungi, and parasites have the same ability. Treatment of these infections raise some different and unique scientific and regulatory issues and the agency would like to receive comments on approaches for dealing with resistance problems that may exist for dealing with these situations. Similarly, the treatment of mycobacterial infections (e.g., tuberculosis or leprosy) raises unique issues and the drugs that are intended to treat these infections are not covered by this rule. The agency would also like to receive comments on approaches to dealing with these drugs as well. Finally, topical antibacterials and topical antiseptics are not covered by this proposal.

II. Description of the Proposed Rule

The proposed rule would amend part 201 (21 CFR part 201) by adding new § 201.24 requiring special labeling for all systemic drug products indicated to treat a bacterial infection, except a mycobacterial infection.

Proposed § 201.24(a) would require that at the beginning of the label, under the product name, the labeling must state that inappropriate use may increase the prevalence of drug resistant microorganisms and may decrease the effectiveness of the drug product and related antimicrobial agents, and that the drug product should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. Proposed § 201.24(b) would require that the “Clinical Pharmacology” section state that appropriate use of the drug product includes, where applicable, identification of the causative microorganism and determination of its susceptibility profile.

Proposed § 201.24(c) would require that the “Indications and Usage” section state that local epidemiology and susceptibility patterns of the listed microorganisms should direct initial selection of the drug product for the treatment of the listed indications and that because of changing susceptibility patterns, definitive therapy should be guided by the results of susceptibility testing of the isolated pathogens.

Proposed § 201.24(d) would require that the “Precautions” subsection entitled “General” state that inappropriate use may increase the prevalence of drug resistant microorganisms and may decrease the future effectiveness of the drug product and related antimicrobial agents. This subsection would also include a statement that the drug product should only be used to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms.

Proposed § 201.24(e) would require that the “Precautions” subsection entitled “Information for Patients” state that patients should be counseled that the drug product should be used only to treat bacterial infections and that it does not treat viral infections. The subsection would also advise physicians to counsel patients that the medication should be taken exactly as directed.

III. Effective Date and Proposed Implementation Plan

FDA proposes that any final rule based on this proposed rule become effective 1 year after the date of its publication in the Federal Register. After that date, new drug applications (NDA's) submitted under 21 CFR 314.50 and abbreviated new drug applications (ANDA's) submitted under 21 CFR 314.94 for systemic antibiotic drug products intended for human use (except those intended to treat mycobacterial infections) would have to comply with the labeling requirements under proposed § 201.24. Holders of approved NDA's or ANDA's would be encouraged to make the labeling changes prior to the effective date of the final rule and would submit supplements that do not require preapproval under 21 CFR 314.70(c) or 21 CFR 314.97. Holders of pending applications would submit amendments under 21 CFR 314.60 or 21 CFR 314.96. To streamline the agency's review, these supplements and amendments would include only the labeling changes proposed in this rulemaking.

IV. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

V. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written assessment of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).

The agency believes this proposed rule is consistent with the regulatory philosophy and principles identified in Executive Order 12866 and in the two statutes cited above. The proposed rule would amend the content of the professional labeling for human prescription antibacterial drugs. Based on the analysis below, as summarized in table 1, FDA projects the annualized costs of complying with the proposed changes to be approximately $0.5 million. The agency also finds that if the proposed rule reduced the excess medical and productivity costs associated with antibacterial resistance by just 1 percent, the annual benefits would exceed $4 million. While FDA has determined that the proposed rule is a “significant regulatory action” as defined in section 3(f)(4) of Executive Order 12866, the proposed rule is not an economically significant rule as described in the Executive Order, because the annual impacts on the economy are substantially below $100 million. With respect to the Regulatory Flexibility Act, the agency certifies that this proposed rule will not have a significant effect on a substantial number of small entities. The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for the proposed rule, because the proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $110 million.

Bacterial resistance to antibacterial drugs directly affects health care costs by requiring the use of newer and more expensive drugs and by requiring longer treatment and hospitalization periods for patients infected by resistant bacteria. Moreover, many disease-producing bacteria adapt to environmental changes and develop resistance to new drugs within a few years of widespread use thereby reducing the effectiveness of new drug therapies (Ref. 13). The societal costs of the infections from these resistant bacteria include both the direct costs for additional drugs and medical care and the indirect costs of lost productivity for patients with extended illness and increased mortality.

1. Direct Costs of Bacterial-Resistant Infections

Most studies on the cost of hospital infections in the United States have not separated infections caused by resistant bacteria from those caused by susceptible bacteria. Researchers from the CDC, examining summary reports of outbreak investigations for 1971 through 1980, as well as published and unpublished reports of infections caused by bacteria with known antibacterial resistance, found that infections from resistant bacteria were typically associated with substantially longer hospital stays. The examined studies, however, had too few subjects to allow statistical analysis (Ref. 14).

Two studies of urban hospitals in the northeastern United States have directly compared the costs of infections caused by resistant and susceptible bacteria. In the first study, using hospital discharge data from hospitals in New York City, researchers modeled differences between infections caused by methicillin-resistant Staphylococcusaureus (MRSA) and those caused by methicillin-sensitive Staphylococcusaureus (MSSA). They estimated that each MRSA infection costs an additional $2,500 in direct medical costs and longer hospital stays (Ref. 15). The death rate attributable to the MRSA infection was more than double that of MSSA infections (i.e., 21 percent versus 8 percent).

In the second study, conducted at a Boston hospital, researchers examined the economic impact of antibiotic resistance in Pseudomonas aeruginosa (Ref. 16). This study compared the mortality rate, length of stay, and costs for three groups: (1) Patients with susceptible bacteria, (2) patients with some baseline resistant bacteria, and (3) patients with resistance that emerged while hospitalized. Daily hospital charges of $2,059 were the same for all three groups. Furthermore, length of stay and mortality rate were similar for patients infected with susceptible bacteria and those with baseline resistant bacteria. However, patients in which resistant bacteria emerged during hospitalization incurred additional costs of $7,340 for 3.5 extra days and had a 250 percent higher mortality rate (27 percent versus 7.7 percent).

The total number of annual infections caused by resistant bacteria is uncertain. Although diagnosis codes exist for infections with drug-resistant microorganisms, they are intended only to supplement other codes for infectious conditions and may not always be included in patient data. As a result, these hospital patient records may provide only an estimate of the minimum number of cases of drug-resistant infections in a given year. The U.S. National Center for Health Statistics publishes annual estimates of the number of diagnoses (by diagnosis code) in nonFederal short-stay hospitals from the National Hospital Discharge Survey (NHDS). For 1995 and 1997, respectively, NHDS estimates suggest about 18,000 and 43,000 cases of infections by resistant microorganisms (Refs. 19 and 20). Data from a larger national sample of hospital patients by the Healthcare Cost and Utilization Project estimate 84,000 diagnoses of resistant infections in community hospitals for 1997 (Ref. 21). Moreover, CDC hospital surveillance data of 5 known strains of resistant bacteria for 1995 suggest a much higher figure, projecting approximately 279,000 cases (Ref. 17). For this analysis, FDA has assumed the average of the 1995 data, or that 150,000 hospital acquired infections per year are attributable to resistant bacteria. Thus, assuming that patients incur additional hospital charges of $2,500 per resistant infection, the total hospital cost attributable to antibacterial resistance is estimated at $375 million annually.

2. Indirect Costs of Bacterial-Resistant Infections

In addition to direct medical costs, patients also incur indirect costs from lost productivity due to resistant bacterial infections. FDA does not know how long a typical hospital stay is extended due to antibacterial resistance. However, if just 1 extra day were needed for relatively simple cases, at an average hourly wage of $16 including benefits, each case would cost about $128 in lost productivity. For cases where few alternatives are effective against the disease-causing bacteria, as withPseudomonas, patients might need an additional 3.5 days in the hospital, with lost productivity cost of about $448 per patient. Assuming the mean of these two estimates, 150,000 cases of resistant bacterial infections would cost the economy about $43 million per year in lost productivity.

3. Reduced Direct and Indirect Costs

In 1997, about 110 million antibacterial prescriptions were written by office-based physicians in the United States (Ref. 18), of which as many as half may have been inappropriate according to the CDC. The proposed rule would alter the professional labeling of these drugs to add concise information relating to the public health risks associated with their inappropriate use. The revised labeling would notify and remind physicians of these risks and prompt physicians to dissuade patients from using antibacterial drugs for diseases not caused by bacteria. These changes are expected to decrease the unnecessary consumption of antibacterial drugs and, in turn, to diminish the growth of antibacterial resistant bacteria. Although FDA cannot quantify the likely magnitude of these effects, if the proposed changes serve to avoid even 1 percent of the above estimated costs of antibacterial resistance, the potential hospital cost savings would amount to $3,750,000 per year in direct costs and $430,000 annually in indirect costs, for a total that exceeds $4 million annually. Moreover, the societal benefits of this rulemaking would be much higher than the economic cost savings because these figures do not include the value of reduced mortality or the benefits of decreasing the rate of development of resistant organisms over time.

B. Costs of Regulation

The proposed rule would require that labeling of systemic antibacterial drug products include information about the inappropriate use of antimicrobial drugs and the link between inappropriate use and the emergence of drug-resistant bacterial strains. The proposed implementation plan would require that labeling for affected prescription drug products comply with the proposed requirements within 1 year after the effective date of the final rule.

1. Affected Products

The proposed rule would affect all systemic antibacterial drug products except those primarily indicated to treat a mycobacterial infection. Antifungal, antiviral, antiparasitic, and topical antimicrobial products would not be subject to the labeling requirements of this proposed rule. Of the approximately 5,300 marketed prescription drug products in the United States, FDA estimates that 737 are antibiotic products, of which 89 are topical products excluded from these requirements.1 The agency estimates that an additional 113 systemic antibacterial drug products would be required to conform to the labeling requirements.2 Thus, a total of 761 drug products may be affected by the proposed rule (table 2).

1 Derived from FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, 1998. Products counted had NDA numbers in the 50,000 or 60,000 series (i.e., antibiotics) and a distinct dosage form or manufacturer. This number, however, may overestimate the number of antibiotic products with distinct labeling.

2 Derived from FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, 1998; and from the 1999 Drug Information, American Hospital Formulary Service (AHFS). Products counted had NDA numbers not in the 50,000 or 60,000 series, active ingredients matching the AHFS list of antibacterial agents, and a distinct manufacturer, active ingredient, or dosage form. Topical dosage forms were excluded.

Industry consultants estimate that, on average, prescription drug manufacturers would incur about $2,000 per product in design and implementation costs for a major revision in the content of professional labeling. Because changes must be made within 1 year of the effective date of the final rule, not all firms will have sufficient time to deplete their inventories of professional labeling. With a 12-month implementation period, consultants estimate per product inventory losses of approximately $570. Thus, including excess inventory losses, the cost to change professional labeling is estimated at $2,600 per product. In the first year, therefore, firms may incur one-time costs of about $2 million.

3. Incremental Printing Costs for Professional Labeling

FDA estimates that an average of 100,000 package inserts may be printed annually for each prescription drug product marketed in the United States.3 Adding new information about prudent use of antibacterial drug products to professional labeling may increase the size of current package inserts by about 4 percent. With such a small change in the length of professional labeling (i.e., 0.4 inch for the average insert), it is unlikely that many package inserts would actually change size. Nevertheless, industry consultants estimate the cost of printing larger labels to be $0.0086 per 100 square inches. Therefore, if the affected products incurred additional printing costs for longer labeling, an estimated $35 per affected product 4 would imply incremental printing costs of less than $30,000 annually.

3 In 1996, there were approximately 133 million prescriptions for antibacterial drugs written by physicians in office and hospital settings (General Accounting Office (GAO) 1999). An estimated 45.3 million inserts accompanied these 761 drug products, or an average of 59,500 inserts per antibacterial product (45.3 million ÷ 761 products). Moreover, an assumed 40,000 additional inserts per product may be distributed annually by sales representatives as promotional material.

The agency estimates that up to 190 products may need slightly longer PDR listings.5 According to its publisher, a printed page in the PDR cost $8,000 in 1998. The additional language would add approximately one-tenth of a page to an average PDR listing, costing $800 per product.6 The annual costs of printing the larger labels in the PDR, therefore, would increase by $0.15 million.

5 190 products is the rounded up estimate from the following calculation: 761 (drug products affected by proposed rule) x .32 (percentage of those products manufactured by innovators) x .75 (percentage of innovator products listed in PDR) = 182.

6 $800 per product = $8,000/page x 1/10 page.

Over 10 years, the agency estimates that the annualized compliance costs of the proposed rule would be approximately $455,000. These costs are summarized in table 3.

The proposed rule would affect manufacturers of systemic antibacterial drug products. There are 600 pharmaceutical manufacturers in the United States. The Small Business Administration (SBA) considers firms with fewer than 750 employees to be small. As seen in table 4 below, Census data classify firms in size categories that do not permit a precise determination of the number of pharmaceutical firms that have fewer than 750 employees. However, Census data do show that more than 90 percent of pharmaceutical manufacturers have fewer than 500 employees, and thus are small businesses.7

7 U.S. Department of Commerce, Bureau of the Census,1992 Census of Manufactures, Industry Series, Drugs, MC92-1-28C.

Approximately 125 large and small firms manufacture systemic antibacterial drug products and thus would be affected by the proposed rule. The estimated annualized costs of $600 per product 8 are relatively modest for most manufacturers of antibiotic drugs. Therefore, the impact of the proposed rule would be significant only for those firms that manufacture many affected products. FDA reviewed the list of approved products 9 and identified only four small domestic firms that manufacture more than three antibiotic products.10 Table 4 compares the estimated costs of compliance to reported average annual sales revenues for pharmaceutical firms of varying sizes. Because almost all manufacturers of antibiotic products in the United States have over 10 employees, the next to the last column of the table shows that these annualized costs are less than one-tenth of one percent of sales revenues. As a result, FDA certifies that this proposed rule would not have a significant adverse effect on a substantial number of small entities.

FDA tentatively concludes that this proposed rule does not require information collections subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (Public Law 104-13).

FDA is proposing to amend its labeling regulations to require that the labeling for systemic antibacterial drug products include certain statements, specified by FDA, about the inappropriate use of antimicrobials and the link between such inappropriate use and the emergence of drug-resistant bacterial strains. These labeling statements are not subject to review by OMB because they are “originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and therefore do not constitute a “collection of information” under the Paperwork Reduction Act of 1995.

Holders of approved NDA's and ANDA's would be required to submit supplements and holders of pending NDA's and ANDA's would be required to submit amendments to comply with the new labeling requirements. The proposed rule would also require that all new NDA's and ANDA's for systemic antibacterial drug products comply with the new labeling requirements. FDA regulations governing the submission and approval of NDA's and ANDA's, including the submission of product labeling, are in part 314 (21 CFR part 314). Recordkeeping and reporting requirements included in part 314 are approved by OMB until November 30, 2001, under OMB control number 0910-0001.

VII. Federalism

FDA has analyzed this proposed rule in accordance with Executive Order 13132. Executive Order 13132 requires Federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt existing State law. As defined in the Order, “policies that have federalism implications” refers to regulations, legislative comments on proposed legislation, and other policy statements or actions that have substantial direct effects on the States, on the relationship between the national government and the States or on the distribution of power and responsibilities among the various levels of government.

The proposal would revise current regulations to require that all systemic antibacterial drug products (i.e., antibiotics and their synthetic counterparts) intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. Because enforcement of these labeling provisions is a Federal responsibility, there should be little, if any, impact from this rule, if finalized, on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. In addition, FDA does not believe that this proposed rule preempts any existing State law.

Accordingly, FDA has determined that this proposed rule does not contain policies that have federalism implications.

VIII. Request for Comments

Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this proposal by December 4, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

IX. References

The following references have been placed on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

6. Mainous, A. G., III, W. J. Hueston, and J. R. Clark, “Antibiotics and Upper Respiratory Infection. Do Some Folks Think There Is a Cure for the Common Cold?,” The Journal of Family Practice, vol. 42, pp. 357-361, 1996.

12. Seppala, H. et al., “The Effect of Changes in the Consumption of Macrolide Antibiotics on Erythromycin Resistance in Group A Streptococci in Finland,” The New England Journal of Medicine, vol. 337, pp. 441-446, 1997.

The labeling of all systemic drug products indicated to treat a bacterial infection, except a mycobacterial infection, must bear the following statements:

(a) At the beginning of the label, under the product name, the labeling must state:

Inappropriate use of (insert name of antibacterial drug product) may increase the prevalence of drug resistant microorganisms and may decrease the effectiveness of (insert name of antibacterial drug product) and related antimicrobial agents.

Use (insert name of antibacterial drug product) only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. See Indications and Usage section.

(b) In the “Clinical Pharmacology” section, the labeling must state:

Appropriate use of (insert name of antibacterial drug product) includes, where applicable, identification of the causative microorganism and determination of its susceptibility profile.

(c) In the “Indications and Usage” section, the labeling must state:

Local epidemiology and susceptibility patterns of the listed micro organisms should direct initial selection of (insert name of antibacterial drug product) for the treatment of the indications listed below. Because of changing susceptibility patterns, definitive therapy should be guided by the results of susceptibility testing of the isolated pathogens.

(d) In the “Precautions” section, under the “General” subsection, the labeling must state:

Inappropriate use of (insert name of antibacterial drug product) may increase the prevalence of drug resistant microorganisms and may decrease the future effectiveness of (insert name of antibacterial drug product) and related antimicrobial agents.

(Insert name of antibacterial drug product) should only be used to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. See Indications and Usage section.

(e) In the “Precautions” section, under the “Information for patients” subsection, the labeling must state:

Patients should be counseled that (insert name of antibacterial drug product) should only be used to treat bacterial infections. It does not treat viral infections (e.g., the common cold).

Patients should also be told that the medication should be taken exactly as directed. Skipping doses and not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop that will not be treatable by (insert name of antibacterial drug product) in the future.

This proposed rule amends section A920 of the Domestic Mail Manual (DMM) to enhance customer service and to provide notice of new safeguards to protect the ownership of customer address lists.

DATES:

Comments must be received on or before October 19, 2000.

ADDRESSES:

Written comments should be sent to Manager, Address Management, USPS, 6060 Primacy Pkwy, Ste 201, Memphis, TN 38188-0001. Copies of all written comments will be available for inspection and photocopying between 9 a.m. and 4 p.m., Monday through Friday, at the above address.

FOR FURTHER INFORMATION CONTACT:

DeWitt Crawford, (901) 681-4612, or Susan Hawes, (901) 681-4661.

SUPPLEMENTARY INFORMATION:

The manual address card sequencing process that has been available for many years has become too labor intensive and expensive for some mailers to maintain. An increasing number of customers have requested the adoption of a more efficient and cost-effective procedure for the sequencing of address lists. In response, the USPS is proposing an electronic address sequencing service for those customers who want to discontinue the production and processing of manual address cards. This proposal is an outgrowth of meetings the USPS conducted with saturation mailer groups and the Mailers Technical Advisory Committee (MTAC).

To ensure the integrity of the qualification process for the electronic sequencing service, all USPS-qualified walk sequence address files will contain seeded addresses known only to the list owner and the USPS. This will help guard against the fraudulent submission of rented lists for qualification. If a request for sequencing contains a seeded address, and all known possibilities of fraud cannot be ruled out, the request will be denied and the owner of the seeded address and the Postal Inspection Service will be notified. Notification will include requester's company name, ZIP Code, and level of address group requested for qualification.

Customers will be allowed three attempts to qualify a ZIP Code within a six-month period. Failure to qualify within this time frame will result in a suspension of one year from further attempts to qualify the ZIP Code.

To protect the integrity of customer address lists, and to add a level of security, all customer requests for DMM A920 card and electronic processing will be posted for 90 days on a password-secured USPS Address Sequencing Service Web site. Company name, ZIP Code, and requested address groups will be listed. This will enable USPS-qualified list owners to monitor possible misuse of their rented or leased address lists. Only USPS-qualified list owners will be able to access the Web site.

Summary of Proposed Change

Proposed DMM sections A920.1.0 through A920.6.4 provide an electronic address sequencing service for those customers who want to discontinue the production and processing of manual address cards.

List of Subjects in 39 CFR Part 111

Administrative practice and procedure, Postal Service.

PART 111—[AMENDED]

1. The authority citation for 39 CFR part 111 is revised to read as follows:

c. Sequencing of address cards or electronic address files, plus inserting cards with addresses for missing or new addresses, or inserting addresses into electronic files for missing or new addresses.

[Revise the heading of 2.0 to read as follows:]

2.0 CARD OR FILE PREPARATION AND SUBMISSION

[Revise 2.1 to read as follows:]

2.1 Color and Size

When submitting cards, all address cards must be made of white or buff-colored card stock and identical in size (5 to 85/16 inches long and 21/4 to 41/4 inches high). Blank cards for missing and/or new addresses must be of the same size as the submitted address cards but of a different color. A customer must provide enough blank cards to equal at least 10 percent of the number of address cards submitted.

[Revise 2.2 to read as follows:]

2.2 Limitation

The customer must not submit address cards or an address file in excess of 110 percent of the possible deliveries for a specific 5-digit ZIP Code delivery area. Customers requesting the service level in A920.1.0c will be allowed three attempts to qualify a ZIP Code for the service within a 6-month period. Failure to qualify within 6 months will result in a suspension of 1 year for any additional attempts to qualify the ZIP Code.

[Revise 2.3 to read as follows:]

2.3 Addressing Format

Addressing format is specific to the media being used.

a. Card Processing—Cards must be faced in the same direction and bear only one address each. The customer's current address information must be computer-generated, typed, or printed along the top of the card. The address must be within 1 inch from the top edge of the card in about the same location on each card submitted. Each card must include a complete address except for the ZIP Code, which is optional. Street designators may be abbreviated as shown in Publication 28, Postal Addressing Standards. When sequence cards are used to obtain address sequencing information for post office boxes, the box section number must be substituted for the carrier route number (if shown).

b. Electronic Processing—The customer must submit address files on electronic media, as described by the USPS. Call the National Customer Support Center at 800-331-5747 for a copy of the required format.

[Revise the first sentence of 2.4 and add second sentence to read as follows:]

2.4 Header Cards

When submitting address cards customers must provide carrier route header cards, prepared with standard 80-column computer card stock (or another size as described above). The header cards must be typed, computer-generated, or printed by the customer. * * *

[Revise 2.5 to read as follows:]

2.5 Delivery Unit Summary

A Delivery Unit Summary must be typed, computer-generated, or printed and provided by the customer for card processing. A printed copy or electronic file will be acceptable for address file submissions. When submitting address cards, an original and two copies must be submitted for each 5-digit ZIP Code delivery area. When submitting an address file, an original and two copies of a printed form or one electronic file must be submitted for each 5-digit ZIP Code delivery area. This form, used by the USPS to provide summary information to the customer, is necessary for calculating total charges for the service level provided. The original is returned to the customer with the cards as the customer's bill. Examples of the required format for the Delivery Unit Summary can be obtained from the National Customer Support Center (see G043).

[Revise the first sentence of 2.6 to read as follows:]

2.6 5-Digit ZIP Codes

When submitting address cards, the cards for each 5-digit ZIP Code area must be placed in separate containers, each with an envelope affixed containing a packing list and Delivery Unit Summary sheets for that 5-digit ZIP Code area. * * *

[Revise 2.7 to read as follows:]

2.7 Submitting Cards or Electronic Files

The designated place for submission of addresses for sequencing depends on the type of media used.

a. Card Processing—The customer must submit the containers of address cards to the district manager of Address Management Systems for carrier routes within the corresponding district. (Exception: Address cards only for addresses in the city where the customer is located may be submitted to the postmaster of that city for sequencing and correction.) Unless otherwise directed, the customer must address containers of address cards to:

* * * Address files can be mailed at the appropriate rate or be electronically transmitted, as determined by the USPS, to the National Customer Support Center. * * *

[Revise 2.9 to read as follows:]

2.9 USPS Sequencing

Unsequenced address cards received at post offices or unsequenced address files received at the National Customer Support Center will be arranged in sequence of carrier route delivery without charge. Cards with incorrect or undeliverable addresses are removed from carrier route bundles, bundled separately, and returned to the customer. When address files are submitted, incorrect or undeliverable addresses are removed from the original file and returned as a separate file.

[Revise the heading and first sentence of 2.10 to read as follows:]

2.10 USPS Time Limits and Billing

The post office or the National Customer Support Center, whichever performs the service, returns the cards or address file and the bill for applicable charges to the customer within 15 working days after receiving a properly prepared request for address sequencing. This time limit does not apply to cards received between November 16 and January 1, which are sequenced as promptly as possible. * * *

[Revise 2.11 to read as follows:]

2.11 Seasonal Addresses

Under all service levels, correct addresses subject to seasonal occupancy, but which do not indicate seasonal treatment, will be identified with an “S” on cards or a flag on address files. If the address is included in a series such as those used for apartment buildings, trailer parks, and seasonal delivery areas in general, the appropriate “seasonal” indicator box is checked on the card or flagged on the address file. When correct address cards or address files are submitted that are not subject to seasonal occupancy, but include seasonal treatment notations, the seasonal indicator is marked out on cards or left blank on address files. For cards, a rubber band is placed around the card to identify it before it is put in carrier route sequence order in the returned deck of cards. No charge is assessed for this service.

USPS employees at post offices (for cards) or the National Customer Support Center (for address files) arrange unsequenced addresses in sequence of carrier route delivery without charge and remove incorrect or undeliverable addresses. Cards are bundled separately for return to the customer, with blank cards inserted for each existing address that is not included in the customer's cards. Address files are returned with missing sequence numbers inserted. (If several addresses in a series are missing, a single blank card is inserted for the series showing the number of missing addresses. For address files a series of missing sequence numbers is inserted identifying the number of missing addresses.)

[Revise 3.2 to read as follows:]

3.2 USPS Time Limits and Billing

The post office or the National Customer Support Center, whichever performs the service, returns the cards or address file along with a bill for applicable charges to the customer within 15 working days after receiving a properly prepared request for address sequencing. This time limit does not apply to cards received between November 16 and January 1, which are sequenced as promptly as possible.

[Revise heading of 4.0 to read as follows:]

4.0 SEQUENCING WITH ADDRESS CARDS OR ADDRESS FILE WITH ADDRESSES ADDED FOR MISSING AND NEW ADDRESSES

[Revise 4.1 to read as follows:]

4.1 USPS Sequencing

USPS employees at post offices (for cards) or the National Customer Support Center (for address files) arrange unsequenced addresses in sequence of carrier route delivery without charge and remove incorrect or undeliverable addresses. New or missing addresses (including rural address conversions to city delivery) are added for each existing address that is not included in the customer's cards or address file. Cards are bundled separately for return to the customer. An address file is returned as a separate file.

[Revise 4.2 to read as follows:]

4.2 Separate Address Groups

Separate groups of address cards must be submitted for the addresses in each 5-digit ZIP Code delivery area: city carrier (residential addresses only); city carrier (business addresses only); city carrier (combination of residential and business addresses); rural and highway contract route addresses; or post office box addresses (whether business, residential, or a combination). If submitting an electronic address file, a single file meeting the same requirements is acceptable. Each group must be accompanied by a statement showing:

a. Types of addresses (i.e., residential, business, or a combination).

b. Number of addresses on the cards or in the address file.

c. Name, mailing address, and telephone number of the list owner or agent.

[Revise 4.4 to read as follows:]

4.4 Address Percentage

For the 5-digit ZIP Code area, the mailing list that the cards or address file represent must contain 90 percent of all possible residential or business city carrier addresses for addresses in the respective address group, 90 percent of all city carrier addresses for addresses in a combination residential/business address group, or 90 percent of all possible deliveries for addresses in rural/highway contract route and post office box groups.

[Revise the heading and the first sentence of 4.6 to read as follows:]

4.6 Resubmitting Cards or Address File

Customers must monitor community growth and determine when address cards or address files need to be submitted for resequencing to maintain the 90 percent eligibility level of address coverage.

5.0 SERVICE CHARGES

[Revise the first sentence of 5.1 to read as follows:]

5.1 Basic Service

For sequencing of address cards or address file, the applicable fee is charged for each address card or address that is removed because of an incorrect or undeliverable address. * * *

[Revise 5.2 to read as follows:]

5.2 Blanks for Missing Addresses

For sequencing of address cards or address file with total possible deliveries shown, the applicable fee is charged for each address card or address that is removed because it is incorrect or undeliverable. No charge is assessed for the insertion of blank cards or missing sequence numbers (for address files) showing the range of missing addresses in a submitted list.

[Revise the first sentence of 5.3 to read as follows:]

5.3 Missing or New Addresses

For sequencing of address cards or address file with missing or new addresses added, the applicable fee is charged for each address card or address that is removed because it is incorrect or undeliverable, and for each address (possible delivery) that is added to the customer's list. * * *

[Amend 5.5 by revising paragraph a to read as follows:]

5.5 Free Services

a. If the customer includes a rural address (box number) in a deck of cards or address file submitted for sequencing, and a street address is assigned to that box number so it can be served on a city delivery route, a correct address card or address is included at no charge.

6.0 SUBMITTING PROPERLY SEQUENCED MAILINGS

[Revise the first sentence of 6.1 to read as follows:]

6.1 Customer Responsibility

The customer must ensure that mailings are prepared in correct carrier route delivery sequence and resequence cards or an address file when necessary. * * *

[Revise 6.2 to read as follows:]

6.2 Changes

If delivery changes occur that affect delivery sequence, but do not cause scheme changes, the customer is notified in writing and must then submit cards or an address file for the affected routes or the complete ZIP Code for resequencing.

[Revise the third sentence of 6.3 to read as follow:]

6.3 Out-of-Sequence Mailing

* * * If the customer does not take corrective action, the USPS gives written notice that the customer is no longer allowed to submit address cards to the post office or address files to the National Customer Support Center for sequencing. * * *

[Revise 6.4 to read as follows:]

6.4 Reinstatement

Generally, a customer denied address card or address file sequencing service for a specific ZIP Code may not submit cards for sequencing at the post office or submit address files for sequencing at the National Customer Support Center where that sequencing service was terminated for 1 year after the effective date of termination. After that time, the customer is again authorized to submit the ZIP Code address cards (to the post office) or an address file (to the National Customer Support Center) for sequencing. At any time during the year after termination of service, the customer may renew the submission if the postmaster (for address cards) or the National Customer Support Center (for address files) is convinced that the customer has taken all necessary action to correct the past errors.

An appropriate amendment to 39 CFR part 111 to reflect these changes will be published if the proposal is adopted.

The FMCSA proposes to implement section 206 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA) by amending the penalty provisions of the rules of practice of the Federal Motor Carrier Safety Regulations (FMCSRs). This action would prohibit a motor carrier that does not pay civil penalties assessed by the FMCSA, or that does not arrange and abide by its payment agreements, from operating in interstate commerce. Furthermore, the registration of a broker, freight forwarder, or for-hire motor carrier that fails to pay a civil penalty would be suspended. The prohibition would begin on the 91st day after the payment date specified in the final agency order or on the 91st day after the due date of a missed payment arranged in a payment plan. Motor carriers that continue to operate would be subject to additional penalties, including revocation of their registrations. However, the prohibition would not apply to anyone who is unable to pay a civil penalty because the person is a debtor in a case under chapter 11 of the Bankruptcy Code.

DATES:

Comments must be received on or before October 19, 2000.

ADDRESSES:

Your signed, written comments must refer to the docket number appearing at the top of this document and you must submit the comments to the Docket Clerk, U.S. DOT Dockets, Room PL-401, 400 Seventh Street, SW., Washington, DC 20590-0001.

All comments received will be available for examination at the above address between 9 a.m. and 5 p.m., e.t., Monday through Friday, except Federal holidays. Those desiring notification of receipt of comments must include a self-addressed, stamped envelope or postcard.

All comments will be available for examination using the docket number appearing at the top of this document in the docket room at the above address. The FMCSA will file comments received after the comment closing date in the docket and will consider late comments to the extent practicable. The FMCSA may, however, issue a final rule at any time after the close of the comment period. In addition to late comments, the FMCSA will also continue to file, in the docket, relevant information becoming available after the comment closing date, and interested persons should continue to examine the docket for new material.

Internet users may access all comments received by the U.S. DOT Dockets, Room PL-401, by using the universal resource locator (URL): http://dms.dot.gov. It is available 24 hours each day, 365 days each year. Please follow the instructions online for more information and help.

An electronic copy of this document may be downloaded using a modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's home page at http://www.nara.gov/fedreg and the Government Printing Office's database at http://www.access.gpo.gov/nara.

Background

Section 206 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA)(Public Law 106-159, 113 Stat. 1748, at 1763) addresses two issues related to delinquent payment of penalties. Section 206(a) amends 49 U.S.C. 13905(c) by authorizing the Secretary of Transportation (Secretary) to suspend, amend, or revoke any part of the registration of a motor carrier, broker, or freight forwarder if that entity has not paid a civil penalty within 90 days of the time specified by official order for payment, or has not arranged and abided by a payment plan. However, the Secretary may not revoke the registration of a person unable to pay penalties because the person is a debtor in a case under chapter 11 of the Bankruptcy Code (11 U.S.C. 362 et seq.)

The term “registration” applies to for-hire motor carriers, freight forwarders, and brokers that register with the FMCSA to provide transportation under 49 U.S.C. chapter 139. This includes entities that held operating authority from the Interstate Commerce Commission as of the effective date of the ICC Termination Act of 1995 (ICCTA) (Public Law 104-88, 109 Stat. 803), as well as entities registered by the Federal Highway Administration (FHWA) after January 1, 1996 and by the Federal Motor Carrier Safety Administration on or after January 1, 2000.

Section 206(b) amends 49 U.S.C. 521(b) to prohibit operations in interstate commerce by an owner or operator of a commercial motor vehicle (CMV) who fails to pay a civil penalty, or to arrange and abide by an acceptable payment plan. A CMV owner or operator must cease its interstate operations if it has not paid its fine within 90 days of the time specified by the Secretary's order for payment, or has not arranged and abided by a payment plan. Similar to the exception contained in section 206(a), the Secretary may not apply this prohibition to anyone unable to pay penalties because the person is a debtor in a case under chapter 11 of the Bankruptcy Code.

Sections of U.S. Code and Implementing Regulations Affected

Section 206(a) of the MCSIA authorizes the Secretary to suspend, amend, or revoke any part of the registration of a motor carrier, broker, or freight forwarder that fails to pay, or fails to abide by a payment plan, for civil penalties imposed under several chapters of title 49 of the United States Code: Chapter 5, Special Authority; Chapter 51, Transportation of Hazardous Materials; Chapter 149, Civil and Criminal Penalties; and Chapter 311, Commercial Motor Vehicle Safety. The subject matter included is quite broad. Chapter 149 encompasses violations of the ICCTA and the commercial regulations. Chapter 311 includes a broad range of safety regulations, most of which are also covered in Chapter 5.

Recommendations of DOT Office of Inspector General

Section 216 of the MCSIA requires the Secretary to implement all of the recommendations contained in the April 26, 1999, report of the Office of the DOT Inspector General (IG) (“Motor Carrier Safety Program,” Report TR-1999-091, available at http://www.oig.dot.gov/hywauds.htm) assessing the effectiveness of the DOT's motor carrier safety programs, “except to the extent to which such recommendations are specifically addressed in sections 206, 208, 217, and 222 of this Act.” One of those recommendations was to “[i]mplement a procedure that removes the operating authority from motor carriers that fail to pay civil penalties within 90 days after final orders are issued or settlement agreements completed,” which is specifically addressed in section 206 of the MCSIA.

The IG report provided the background for its recommendation in the following narrative:

Standards for administrative collection of penalties, cited in Code of Federal Regulations, Title 4, Volume 1, Section 102.9, allow agencies to suspend or revoke licenses or operating authority for nonpayment of fines. However, OMC [the FHWA's former Office of Motor Carriers, now the FMCSA] has not exercised these sanctions. For example, one motor carrier has had $126,653 in outstanding fines since October 1995 and continues normal operations. Another motor carrier has a penalty in excess of $22,000, which has been outstanding for more than four years. OMC's records indicate a settlement was reached between this motor carrier and the Department of Justice; however, OMC has not received payment. In addition, OMC's records indicate the motor carrier had a more recent penalty assessment in excess of $17,000. The continued practice of permitting motor carriers with outstanding fines or repetitive penalties to continue normal operations limits the effectiveness of OMC's enforcement program.

The subject matter of this NPRM is limited to the sanctions provided in section 206 of the MCSIA for failure to pay civil penalties imposed under the procedures of 49 CFR part 386.

The following table summarizes the recent history of the FHWA and the FMCSA civil fines and forfeitures. The number of new cases has fluctuated considerably from year to year. Following the decision in the MST Express v. Federal Highway Administration, 108 F. 3d 401 (D.C. Cir. 1997) case, which held that the FHWA's safety fitness rating methodology was invalid because it was not published in accordance with the notice-and-comment requirements of the Administrative Procedure Act (5 U.S.C. 553), the FHWA published an interim final rule reestablishing the rating system for motor carriers of passengers and hazardous materials and later issued a final rule establishing a new safety rating system (62 FR 60035, November 6, 1997). Although the decision in MST Express did not prohibit the FHWA from bringing new civil penalty actions, which are independent of the rating process, it had the effect of reducing the number of compliance reviews, which are a primary generator of enforcement actions. In addition, some motor carriers that would have requested compliance reviews to upgrade a conditional or an unsatisfactory safety rating, and some unrated carriers, probably did not request compliance reviews during the time the decision in MST Express was in force, because the agency would not have been able to change a rating of record or to issue a new rating during this time.

The following table provides a summary history of civil fines and forfeitures assessed and collected by the FMCSA and its predecessor agencies. The data in this table reflect fiscal records (accounts receivables) that cover enforcement actions that cross fiscal years.

The amounts written off varied considerably from year to year. The largest reductions in write-offs are due to a motor carrier's bankruptcy and motor carriers that had gone out of business.

Penalty Procedure

The rules of practice for motor carrier proceedings are contained in 49 CFR part 386. They were recently amended (65 FR 7753, February 16, 2000) to include proceedings concerning violations of the commercial regulations that were formerly implemented and administered by the Interstate Commerce Commission. The purpose of the amendment was to ensure that all civil forfeiture and investigation proceedings instituted by the FMCSA are governed by uniform and consistent procedures.

A Notice of Claim (NOC) is the official charging document used by the agency to initiate an enforcement action for violations of applicable provisions of the FMCSRs (49 CFR parts 350-399, including the commercial regulations (49 CFR parts 360-379)) and the Hazardous Materials Regulations (HMRs, 49 CFR parts 171-180). The NOC lays the foundation for the claim. Among other things, it lists the violations discovered during the compliance review conducted at a specified location on certain date(s), that the agency intends to prosecute; provides a statement of the provisions of the regulations or law alleged to have been violated; and a brief statement of facts regarding the violations. The NOC also specifies the amount being claimed for each violation and the maximum amount authorized to be claimed under the statute. The rules for commencement of proceedings and for pleadings are described at 49 CFR part 386, subpart B.

An NOC is issued by the appropriate FMCSA State Director within 20 business days of the completion of the compliance review or investigation. To establish a record of delivery, it is mailed certified/return receipt requested to U.S. respondents and sent registered/return receipt requested by commercial express courier service to foreign respondents.

The NOC provides specific instructions to motor carriers on their response options. A motor carrier may pay its penalty in full—the agency advises the motor carrier to do so within 25 business days. The motor carrier may also request a monthly payment schedule to settle the claim. This request must be made within 25 days of service of the NOC. Finally, the motor carrier may contest the NOC and request a hearing on the record on any material issues of fact in dispute—the motor carrier must file a written request for a hearing within 15 days of service of the NOC. If the motor carrier does not file such a request, it waives its right to a hearing.

If the motor carrier does not respond to the FMCSA, the NOC becomes the Final Agency Order (FAO) by default 25 days after the NOC was served and the carrier is so notified.

The FAO is a notice of the outstanding debt the motor carrier owes the Federal government. It may be issued following a proceeding before the Chief Safety Officer 1 or an Administrative Law Judge, or it may follow a carrier's default as discussed above. An order issued by the Chief Safety Officer is final on the day it is served and specifies a payment due date. An order issued by an Administrative Law Judge is final 45 days after it is served (unless it is modified by the Chief Safety Officer); it will also specify a payment due date.

1 The Chief Safety Officer is also the Assistant Administrator of the FMCSA (Title 1, Sec. 101 of the Motor Carrier Safety Improvement Act of 1999 (Public Law 106-159, 113 Stat. 1750, December 9, 1999).

If the motor carrier appeals the FAO to a Federal Circuit Court of Appeals, the terms and payment due date of the FAO are not stayed unless the Court so specifies.

The FAO advises the motor carrier that, in addition to the amount of the penalty assessed, the motor carrier may be liable for interest and administrative penalties based upon the outstanding balance. The respondent must pay the fine within 30 days of receipt of the FAO. The respondent may petition the FMCSA for reconsideration of the FAO within 20 days after it is served.

If the motor carrier has not paid its fine in full, or if it has not executed an agreement with the appropriate FMCSA Service Center for a payment schedule for its fine, an accounts receivable memorandum is issued by the FMCSA to the FHWA Finance Division which will pursue collection through administrative channels. (The FHWA is providing certain administrative support for the FMCSA under an interagency agreement until the FMCSA is authorized to fully staff its administrative offices.) If the agency has not received payment 30 days after the FAO is served on a motor carrier, the FHWA will send a letter to the motor carrier by certified mail, return receipt requested. The agency sends additional letters if it has still not received payment by 60 days and 90 days after service of the order. After 180 days, the FHWA refers the case to the Department of Treasury for collection of the fine in accordance with the Debt Collection Improvement Act of 1996, Pub. L. 104-134, 110 Stat. 1321-358.

This NPRM would add one additional step to the penalty procedure. If the FMCSA has not received payment 45 days after service of the FAO, the agency will send the motor carrier a letter by certified mail, return receipt requested. This 45-day letter would provide the motor carrier one additional notice that its operations in interstate commerce (in the case of private and for-hire motor carriers) and its operating authority (in the case of authorized for-hire motor carriers, brokers, and freight forwarders) may be suspended on the 91st day after service of the FAO. Section 206 of the MCSIA specifically states that the cessation of operations and suspension of operating authority provisions do not apply to motor carriers unable to pay civil penalties because they are debtors in bankruptcy proceedings under chapter 11 of the Bankruptcy Code. Therefore, those carriers must provide the following information: (1) The chapter of the Bankruptcy Code under which the bankruptcy proceeding is filed (i.e., Chapter 7 or 11); (2) the bankruptcy case number; (3) the court in which the bankruptcy proceeding was filed; and (4) any other information requested by the agency to determine a debtor's bankruptcy status. This written response by the debtor will enable the FMCSA to verify debtor status and to assess the debtor's ability to pay penalties.

Motor carriers, freight forwarders, and brokers are cautioned, however, not to construe the 45-day letter as an opportunity to reargue the merits of the penalty assessment, or put into issue their ability to pay. They will have had several opportunities to address these concerns with the FMCSA at earlier stages in the penalty procedure. The only written response from a carrier, broker, or freight forwarder sufficient to prevent suspension of operations and operating authority, would be proof of payment, or proof of bankruptcy debtor status.

Brokers, freight forwarders, and for-hire motor carriers that continue to operate in interstate commerce in violation of the suspension of their operating authority may have that authority revoked after notice and opportunity for a proceeding in accordance with 49 U.S.C. 13905(c). Additional sanctions may be imposed under paragraph IV (h) of Appendix A to part 386 on all carriers, freight forwarders, and brokers that operate during a period of suspension.

Motor Carriers Subject to Penalties

Part 386 defines a motor carrier as a [for-hire] motor carrier, motor private carrier, or motor carrier of migrant workers as defined in 49 U.S.C. 13102 and 31501 (65 FR 7753 at 7756, February 16, 2000). There are currently two categories of motor carriers of passengers warranting special mention: (1) Non-business private motor carriers of passengers, such as, churches or social groups, and (2) owners and operators of vehicles designed to transport fewer than 16 passengers, including the driver, for compensation.

Non-business private motor carriers of passengers are not required to maintain most of the records otherwise mandated by the FMCSRs and do not receive safety ratings from the FMCSA. However, they are still subject to many of the substantive regulations and to safety enforcement at roadside. Violations of the FMCSRs, HMRs, or the commercial regulations discovered during the course of a compliance review or at roadside could subject these motor carriers to enforcement action and other sanctions. In addition, if a motor carrier in this category were found to have such unsafe operational practices and/or to have committed such severe safety violations as to make it an imminent hazard to public health, the FMCSA may issue an imminent hazard out-of-service order under 49 CFR 386.72.

The second category of passenger motor carrier of interest is comprised of for-hire operators of limousines and vans that are designed to transport between 9 and 15 passengers, including the driver. These for-hire motor carriers were required to register and obtain operating authority from the former Interstate Commerce Commission. Since 1996, they have been required to register with the FHWA's former Office of Motor Carriers, now the FMCSA. They were not subject to most provisions of the FMCSRs because their vehicles were not considered “commercial motor vehicles” under 49 CFR 390.5—the definition covered only passenger vehicles designed to transport 16 or more passengers, including the driver.

In 1998, section 4008 of the Transportation Equity Act for the 21st Century (TEA-21) (Public Law 105-178, 112 Stat. 107, at 405, June 9, 1998) changed the statutory definition of “commercial motor vehicle” to include those designed or used to transport “more than 8 passengers (including the driver) for compensation” (49 U.S.C. 31132(1)(B)). Most of the FMCSRs (except parts 382, 383, and a few other requirements) became applicable to these smaller passenger vehicles on June 9, 1999; subpart B of part 387, minimum levels of financial responsibility for for-hire motor carriers of passengers, already was applicable to those carriers subject to the registration requirements.

Section 212 of the MCSIA subsequently required the FMCSA to amend the FMCSRs to cover certain commercial motor vehicles designed or used to transport between 9 and 15 passengers (including the driver) for compensation. At a minimum, the Congress indicated that the rulemaking shall apply the FMCSRs to “camionetas,” commercial vans operating in the area of the U.S.-Mexico border, as well as those commercial vans operating in interstate commerce that have been determined to pose serious safety risks. A rulemaking on this topic is under development. As this class of carriers becomes subject to the FMCSRs, they will also be subject to the consequences proposed in today's NPRM—namely, revocation of operating authority and prohibition against operating in interstate commerce, if they fail to pay civil penalties assessed by the FMCSA.

Motor Carriers With Penalties Outstanding

This rulemaking will not be retroactive. The provisions of this proposed action would apply only to penalties included in FAOs issued on or after the effective date of a final rule issued in this matter. There is nothing in the language of section 206 of the MCSIA that suggests that the Congress intended it to apply retroactively. As the FMCSA noted in the preamble to the final rule concerning the application of the provisions of section 4009 of the TEA-21 (Safety Fitness), the Supreme Court's discussion of retroactive and prospective application of laws in Landgraf v. USI Film Products, 511 U.S. 244 (1994), was carefully nuanced. It said, among other things:

When a case implicates a federal statute enacted after the events in suit, the court's first task is to determine whether Congress has expressly prescribed the statute's proper reach. If Congress has done so, of course, there is no need to resort to judicial default rules. When, however, the statute contains no such express command, the court must determine whether the new statute would have retroactive effect, i.e., whether it would * * * increase a party's liability for past conduct * * * If the statute would operate retroactively, our traditional presumption teaches that it does not govern absent clear congressional intent favoring such a result.

Id., at 280.

We find that section 206 of the MCSIA includes no “express command” to shut down motor carriers based on non-payment of penalties assessed before the provision was enacted. Therefore, the presumption against retroactive application of laws applies.

Exclusion of Chapter 11 Debtors

The final paragraphs of MCSIA sections 206(a) and (b) note that the suspension or revocation of registration and the prohibition on operation in interstate commerce after nonpayment of penalties “shall not apply to any person who is unable to pay a civil penalty because such person is a debtor in a case under Chapter 11 of title 11, United States Code.”

The FMCSA believes that the Congress, in creating the bankruptcy exemption, did not intend to exempt all Chapter 11 debtors from the license suspension/revocation provision and the requirement to cease operations in interstate commerce. The express language of the statutory exemption applies not to all Chapter 11 debtors, but to any person who is unable to pay a civil penalty by reason of being in Chapter 11. Congress recognized that the determination of whether a Chapter 11 debtor is able to pay certain debts is within the jurisdiction of the bankruptcy court. The FMCSA interprets the statutory language as requiring the agency to seek a determination from the bankruptcy court that a motor carrier is able to pay a civil penalty claim prior to imposing a suspension of its operating authority or ordering it to cease its interstate operations.

Under the automatic stay provisions of the Bankruptcy Code, a petition filed in bankruptcy “operates as a stay, applicable to all entities of—(1) the commencement or continuation * * * of a judicial, administrative, or other action or proceeding against the debtor that was or could have been commenced before the commencement of the bankruptcy case. * * *” 11 U.S.C. 362(a). However, “the filing of a petition * * * does not operate as a stay—(4) * * * of the commencement or continuation of an action or proceeding by a governmental unit to enforce such governmental unit's police or regulatory power * * * and (5) * * * Of the enforcement of a judgment, other than a monetary judgment, obtained in an action or proceeding by a governmental unit to enforce such unit's police or regulatory power.” 11 U.S.C 362(b).

In determining whether an agency action fits within the exemption of section 362(b)(4), the courts have developed the “public policy” test which distinguishes between governmental proceedings aimed at effectuating public policy and those aimed at protecting the government's pecuniary interest in the debtor's property. See Eddleman v. U.S. Department of Labor, 923 F. 2d 782 (10th Cir. 1991); and NLRB v. Edward Cooper Painting, Inc., 804 F. 2d 934 (6th Cir. 1986). Agency proceedings under section 206 of the MCSIA are clearly designed to bring about the public policy of encouraging compliance with the FMCSRs, HMRs, and commercial regulations. As a result, filing for bankruptcy protection under Chapter 11 or any other chapter does not automatically relieve a motor carrier, broker, or freight forwarder from its regulatory obligations.

Relationship of Penalty Provision to Safety Rating

As a result of section 15(b) of the Motor Carrier Safety Act of 1990 (Public Law 101-500, 104 Stat. 1218), motor carriers receiving an unsatisfactory safety rating from the FHWA/FMCSA have been prohibited from using CMVs to transport more than 15 passengers, including the driver, or placardable quantities of hazardous materials, in interstate commerce. Furthermore, those motor carriers could not be used by Federal agencies. These prohibitions and the procedures for applying them are contained in 49 CFR 385.13. Section 4009 of the TEA-21 extended a similar prohibition to all other motor carriers, irrespective of their cargo, which are found by the FMCSA to be unfit. These owners and operators may not operate CMVs in interstate commerce beginning on the 61st day after such fitness determination. Regulations have been issued to implement this provision (65 FR 50919, August 22, 2000).

There are circumstances when the FMCSA assesses penalties against a motor carrier but does not assign that motor carrier an unsatisfactory safety rating. However, under the rules proposed today, the impact of an unpaid fine on a motor carrier's operations would be the same—the motor carrier would be prohibited from operating CMVs in interstate commerce. Those motor carriers that do not pay civil penalties or abide by payment plans as required will be in violation of the law.

Discussion of Proposal

The proposed changes to 49 CFR part 386 are a straightforward implementation of the amendments to 49 U.S.C. 521(b) and 13905(c) made by section 206 of the MCSIA. The regulatory changes prohibit interstate operations by motor carriers delinquent in payment of penalties assessed by the FMCSA, unless the motor carrier is unable to pay because it is a debtor in a case under Chapter 11, title 11, United States Code. Brokers, freight forwarders, and for-hire motor carriers may also have their registrations suspended, amended, or revoked for failure to pay civil penalties in a timely manner.

The proposed rule would apply prospectively. It would only apply to FAOs issued on or after the effective date of the final rule. FAOs issued before that date would not be subject to the provisions of the rule.

The FMCSA is providing a comment period of 30 days on this proposed rule. While E.O. 12866 and DOT policy generally favor at least a 60-day period, FMCSA is setting an earlier deadline in order to meet the statutory deadline for issuing the final rule.

The FMCSA has determined that this proposed regulatory action is not significant within the meaning of Executive Order 12866 nor under the regulatory policies and procedures of the DOT. This proposed rule would require any motor carrier in interstate commerce that had not paid a penalty assessed by the FMCSA within 90 days of the final agency order, or had not abided by a payment plan that it had arranged with the FMCSA, from providing interstate transportation.

As of May 25, 2000, the FMCSA's MCMIS and Enforcement Tracking Systems and the FHWA's DAFIS fiscal accounting system contained the following information concerning motor carrier enforcement cases that resulted in fines being assessed:

The number of motor carriers with fines outstanding is a minute fraction of the motor carriers in the FMCSA's MCMIS. For example, in fiscal year 1999, 380 motor carriers had not paid their fines, or were more than 30 days overdue in their payment plans. In that year, there were approximately 500,000 motor carriers listed as active. However, the dollar value of the outstanding claims is substantial (see Tables 1 and 4), and has remained relatively constant over time.

Table 6 expands upon the information contained in Table 2 and illustrates the payment records from motor carriers of different size categories for Federal fiscal year 1999, the most recent year for which a full year's worth of data is available.

Finally, the data from a recent FHWA report of accounts receivable (as of April 30, 2000, and covering accounts for the prior 12 month period) provides a snapshot of motor carriers' progress in adhering to their payment plans. Because of the particular reporting period, the data in Table 7 is not directly comparable to the other tables. However, the average principal per account is comparable to the “Billings outstanding” figures in Table 5.

Out of the 896 cases, 670 (75 percent) of the motor carriers would be able to continue operating in interstate commerce under the provisions of the NPRM, provided that no other sanctions (such as a determination of unfitness) had been issued. (Because of the accounting case coding method used, there is no readily available breakdown by the size categories of motor carriers, nor could we determine readily how these cases were divided among U.S., Canadian, or Mexican motor carriers.) Not shown in the table are an additional 1,539 cases that were delinquent over 181 days—these had been referred to the Department of Treasury for collection, and include cases referred prior to May 1999.

Based upon the data presented here, the FMCSA anticipates that this rulemaking will have minimal economic impact on the interstate motor carrier industry. Statistics on enforcement actions taken during each of Federal fiscal years 1996 through 1999 indicate that approximately 300 to 500 motor carriers per year did not pay their assessed penalties within 90 days after receiving a final agency order. Under the proposed regulations, these motor carriers would be required to cease their operations in interstate commerce until they paid their penalties. That sanction may induce most such motor carriers to pay the civil penalty within 90 days or to abide by their agreed-upon payment plans. It is assumed that the costs of paying the fines, which have historically averaged between 3,500 and 5,500, would be less than the potential significantly higher cost of not paying, and facing the shutdown of interstate operations. Thus, the entities involved would take steps to achieve compliance with the lower cost alternative. For the purpose of this analysis, the FMCSA estimates that between 50 and 75 percent of these motor carriers would pay their fines within 90 days rather than face additional sanctions. Therefore, approximately 75 to 250 motor carriers annually might not pay their assessed fines and would face the penalties attached to this proposed rule. This estimate is conservative because it does not account for those motor carriers in Chapter 11 bankruptcy proceedings that would not be subject to this proposed rule.

As noted above, the data presented also show that the average fines assessed on the motor carriers range between 3,500 and 5,500. The majority of fines that are paid under payment plans arranged with the FMCSA —75 percent—are not more than 90 days in arrears. However, this analysis is limited to the subject of this NPRM, namely, timely payment of fines. It does not take into consideration the final rule concerning “unfit” motor carriers that the agency published in the Federal Register on August 22, 2000 (65 FR 50919). That rulemaking implements the provisions of section 4009 of TEA-21 (Pub. L. 105-178, Title, IV, section 4009(a), 112 Stat. 405, (June 9, 1998)). Some carriers may be forced to halt operations both because they have an unsatisfactory safety rating and because they have not paid outstanding penalties. Although this number may be small, it complicates the task of separately determining the impact of this rule. The agency is interested in any information that will help to determine the economic impact of this proposed rule on motor carrier transportation and any additional impacts on industry customers.

Based upon its analysis of statistical information concerning motor carriers' improvement in their safety ratings, the FMCSA believes that the vast majority of motor carriers interested in continuing their operations would be able to do so. The adverse impact that this rule would have on those few motor carriers not involved in bankruptcy proceedings which fail to pay their penalties in a timely manner, is exactly the effect intended by Congress.

This proposed rule would only affect the operations of the small number of motor carriers that do not pay civil penalties assessed as part of enforcement actions. The number of motor carriers involved is expected to continue to be extremely small—fewer than one-tenth of one percent of motor carriers per year listed as active in the MCMIS. The FMCSA believes the number of motor carriers potentially subject to this level of impact is much smaller than the number of motor carriers that cease operations as a result of normal economic fluctuations. This rulemaking reinforces the importance of complying with the safety regulations by putting into place a mechanism to require motor carriers to pay penalties assessed, unless they are unable to pay because they are debtors in Chapter 11 bankruptcy proceedings.

This rulemaking imposes no requirements that would generate new costs for motor carriers, brokers, and freight forwarders. Those entities would see no change to their operations, provided they pay assessed monetary penalties within the time frames that they arrange with the FMCSA. Based upon the extremely small number of motor carriers projected to be affected, the agency believes that the overall adverse economic effects of this rulemaking would be minimal. This rulemaking, if adopted, would allow the FMCSA to require those very few motor carriers that do not pay civil penalties, or abide by payment agreements, to cease their operations in interstate commerce. Brokers, freight forwarders, and for-hire motor carriers operating in interstate commerce would also lose their operating authority until they paid their overdue civil penalties. This proposed rule would provide the FMCSA with an essential tool to take prompt and effective action against these motor carriers.

This rulemaking would not result in inconsistency or interference with another agency's actions or plans. The FMCSA believes that the rights and obligations of recipients of Federal grants will not be materially affected by this regulatory action.

Regulatory Flexibility Act

In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-612) the FMCSA has evaluated the effects of this proposed rulemaking on small entities. The motor carriers that would be economically impacted by this rulemaking would be those who do not pay their civil penalties by the 90th day after the FMCSA's final agency order or that have failed to arrange and abide by a payment plan.

Motor carriers can avoid the consequences of this proposed rule simply by paying their civil penalties. The FMCSA does not assess fines at a level that would cause a motor carrier to shortchange its safety and soundness of operations in order to pay its fine. In determining the level of penalties, the FMCSA takes into account, among other things, a motor carrier's ability to pay. The FMCSA also allows motor carriers to arrange a payment plan with the agency. Both of these considerations are tailored to the financial needs of small motor carriers and are part of the agency's current procedures. Therefore, the FMCSA hereby certifies that this regulatory action would not have a significant economic impact on a substantial number of small entities. The FMCSA invites public comment on this determination.

Unfunded Mandates Reform Act of 1995

This proposed rule would not impose a Federal mandate resulting in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C 1531 et seq.).

We have analyzed this proposal under Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks.” This proposed rule is not economically significant and does not concern an environmental risk to health or safety that would disproportionately affect children.

Executive Order 12630 (Taking of Private Property)

This proposed rule would implement a statutory mandate to prohibit motor carriers that do not pay assessed penalties from operating in interstate commerce. Motor carriers can avoid all of the implications of this mandate by complying with the FMCSRs, thereby avoiding adverse enforcement actions. Failing that, the motor carrier can avoid the new sanctions this NPRM would attach by paying penalties assessed within 90 days of the final agency order. If the motor carrier arranges a payment plan with the FMCSA, it can avoid the new sanctions by abiding by its payment plans. The FMCSA therefore certifies that this rule has no takings implications under the Fifth Amendment or Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Executive Order 13132 (Federalism)

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999. The FMCSA has determined this proposed rule does not have a substantial direct effect on, or sufficient federalism implications for, the States, nor would it limit the policymaking discretion of the States.

These proposed changes to the FMCSRs would not directly preempt any State law or regulation. They would not impose additional costs or burdens on the States. Although the FMCSA is revising part 386 of the FMCSRs, States are not required to adopt part 386 as a condition for receiving Motor Carrier Safety Assistance Program grants. Also, this action would not have a significant effect on the States' ability to execute traditional State governmental functions.

Executive Order 12372 (Intergovernmental Review)

Catalog of Domestic Assistance Program Number 20.217, Motor Carrier Safety. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.

Paperwork Reduction Act

This proposed action would not involve an information collection that is subject to the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.

National Environmental Policy Act

The agency has analyzed this proposal for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and has determined that this action would not have an adverse effect on the quality of the environment.

Regulatory Identification Number

A regulatory identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN contained in the heading of this document can be used to cross reference this action with the Unified Agenda.

(a) A motor carrier that has failed to pay civil penalties imposed by the FMCSA, or has failed to abide by a payment plan, may be prohibited from operating CMVs in interstate commerce under 49 CFR 386.83.

(b) A broker, freight forwarder, or for-hire motor carrier that has failed to pay civil penalties imposed by the FMCSA, or has failed to abide by a payment plan, may be prohibited from operating in interstate commerce, and its registration may be suspended under the provisions of 49 CFR 386.84.

The rules in this part govern proceedings before the Assistant Administrator, who also acts as the Chief Safety Officer of the Federal Motor Carrier Safety Administration (FMCSA), under applicable provisions of the Federal Motor Carrier Safety Regulations (49 CFR parts 350-399), including the commercial regulations (49 CFR parts 360-379)) and the Hazardous Materials Regulations (49 CFR parts 171-180). The purpose of the proceedings is to enable the Assistant Administrator to determine whether motor carriers, property brokers, freight forwarders, or their agents, employees, or any other person subject to the jurisdiction of the FMCSA, have failed to comply with the provisions or requirements of applicable statutes and the corresponding regulations and, if such violations are found, to issue an appropriate order to compel compliance with the statute or regulation, assess a civil penalty, or both.

5. In § 386.2, remove “Federal Highway Administration” and add “Federal Motor Carrier Safety Administration” each place it appears; and add the new definitions of Assistant Administrator, Broker, Final agency order, and Freight forwarder, in alphabetical order, to read as follows:

§ 386.2 Definitions.

Assistant Administrator means the Assistant Administrator of the Federal Motor Carrier Safety Administration. The Assistant Administrator is the Chief Safety Officer of the agency pursuant to 49 U.S.C.113(d), and the final agency decisionmaker in motor carrier safety and hazardous materials proceedings under this part.

Broker means a person who, for compensation, arranges or offers to arrange the transportation of property by an authorized motor carrier. Motor carriers, or persons who are employees or bona fide agents of carriers, are not brokers within the meaning of this section when they arrange or offer to arrange the transportation of shipments which they are authorized to transport and which they themselves have accepted and legally bound themselves to transport.

Final agency order means a notice of final agency action issued pursuant to this part by either the appropriate FMCSA Field Administrator (for default judgements under § 386.14(e)), the FMCSA Chief Safety Officer, or an Administrative Law Judge (ALJ), typically requiring payment of a civil penalty by a broker, freight forwarder, or motor carrier.

Freight forwarder means a person holding itself out to the general public (other than as an express, pipeline, rail, sleeping car, motor, or water carrier) to provide transportation of property for compensation in interstate commerce, and in the ordinary course of its business:

(1) Performs or provides for assembling, consolidating, break-bulk, and distribution of shipments;

(2) Assumes responsibility for transportation from place of receipt to destination; and

(3) Uses for any part of the transportation a carrier subject to FMCSA jurisdiction.

(a)(1) General rule. A motor carrier that fails to pay a civil penalty in full within 90 days after the date specified for payment by the FMCSA's Final Agency Order is prohibited from operating in interstate commerce starting on the next (i.e., the 91st) day. The prohibition continues until the FMCSA has received full payment of the penalty.

(2) Civil penalties paid in installments. The FMCSA Service Center may allow a motor carrier to pay a civil penalty in installments. If the motor carrier fails to make an installment payment on schedule, the payment plan is void and the entire debt is payable immediately. A motor carrier that fails to pay the full outstanding balance of its civil penalty within 90 days after the date of the missed installment payment, is prohibited from operating in interstate commerce on the next (i.e., the 91st) day. The prohibition continues until the FMCSA has received full payment of the entire penalty.

(3) Appeals to Federal Court. If the motor carrier appeals the final agency order to a Federal Circuit Court of Appeals, the terms and payment due date of the final agency order are not stayed unless the Court so specifies.

(b)(1) Notification of delinquent payment. The FMCSA will notify the motor carrier in writing if it has not received payment within 45 days after the date specified for payment by the final agency order or the date of a missed installment payment. The notice will include a warning that failure to pay the entire penalty within 90 days after payment was due, will result in the motor carrier being prohibited from operating in interstate commerce.

(2) The notice will be delivered by certified mail or commercial express service. If a motor carrier's principal place of business is in a foreign country, it will be delivered to the motor carrier's designated agent.

(c) Motor carriers that continue to operate in interstate commerce in violation of this section may be subject to additional sanctions under paragraph IV (h) of Appendix A to part 386.

(d) This section does not apply to any person who is unable to pay a civil penalty because the person is a debtor in a case under chapter 11, title 11, United States Code. Motor carriers in bankruptcy proceedings under chapter 11 must provide the following information in their response to the FMCSA:

(1) The chapter of the Bankruptcy Code under which the bankruptcy proceeding is filed (i.e., Chapter 7 or 11);

(2) The bankruptcy case number;

(3) The court in which the bankruptcy proceeding was filed; and

(4) Any other information requested by the agency to determine a debtor's bankruptcy status.

§ 386.84 Sanction for failure to pay civil penalties or abide by payment plan; suspension or revocation of registration.

(a)(1) General rule. The registration of a broker, freight forwarder, or for-hire motor carrier that fails to pay a civil penalty in full within 90 days after the date specified for payment by the FMCSA's final agency order, will be suspended starting on the next (i.e., the 91st) day. The suspension continues until the FMCSA has received full payment of the penalty.

(2) Civil penalties paid in installments. The FMCSA Service Center may allow a respondent broker, freight forwarder, or for-hire motor carrier to pay a civil penalty in installments. If the respondent fails to make an installment payment on schedule, the payment plan is void and the entire debt is payable immediately. The registration of a respondent that fails to pay the remainder of its civil penalty in full within 90 days after the date of the missed installment payment, is suspended on the next (i.e., the 91st) day. The suspension continues until the FMCSA has received full payment of entire penalty.

(3) Appeals to Federal Court. If the motor carrier appeals the final agency order to a Federal Circuit Court of Appeals, the terms and payment due date of the final agency order are not stayed unless the Court so specifies.

(b)(1) Notification of delinquent payment. The FMCSA will notify a respondent broker, freight forwarder, or for-hire motor carrier in writing if it has not received payment within 45 days after the date specified for payment by the final agency order or the date of a missed installment payment. The notice will include a warning that failure to pay the entire penalty within 90 days after payment was due, will result in the suspension of the respondent's registration.

(2) The notice will be delivered by certified mail or commercial express service. If a respondent's principal place of business is in a foreign country, it will be delivered to the respondent's designated agent.

(c) The registration of a broker, freight forwarder or for-hire motor carrier that continues to operate in interstate commerce in violation of this section may be revoked after notice and opportunity for a proceeding in accordance with 49 U.S.C. 13905(c). Additional sanctions may be imposed under paragraph IV (h) of Appendix A to part 386.

(d) This section does not apply to any person who is unable to pay a civil penalty because the person is a debtor in a case under chapter 11, title 11, United States Code. Brokers, freight forwarders, or for-hire motor carriers in bankruptcy proceedings under chapter 11 must provide the following information in their response to the FMCSA:

(1) The chapter of the Bankruptcy Code under which the bankruptcy proceeding is filed (i.e., Chapter 7 or 11);

(2) The bankruptcy case number;

(3) The court in which the bankruptcy proceeding was filed; and

(4) Any other information requested by the agency to determine a debtor's bankruptcy status.

Appendix A to Part 386 [Amended]

7. Add paragraph h to part IV of Appendix A to part 386 to read as follows:

h. Violation—conducting operations during a period of suspension under § 386.83 or § 386.84 for failure to pay penalties.

Penalty—Up to $10,000 for each day that operations are conducted during the suspension period.

[FR Doc. 00-24105 Filed 9-18-00; 8:45 am]BILLING CODE 4910-22-PDEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Reopening of Comment Period and Notice of Availability of Draft Economic Analysis on Proposed Critical Habitat Designation for the Great Lakes Breeding Population of the Piping PloverAGENCY:

Fish and Wildlife Service, Interior.

ACTION:

Proposed rule; reopening of comment period and notice of availability of draft economic analysis.

SUMMARY:

The U.S. Fish and Wildlife Service (Service) announces the availability of the draft economic analysis of the proposed designation of critical habitat for the Great Lakes breeding population of the piping plover. We also provide notice of the reopening of the comment period for the proposal to allow all interested parties to submit written comments on the proposal and on the draft economic analysis. The new comment period will allow all interested parties to submit comments on the draft Economic Analysis and proposed designation. Comments received on the proposal after the close of the original comment period but before this reopening will be incorporated into the public record as a part of this reopening and do not need to be resubmitted.

DATES:

The original comment period for the critical habitat proposal closed on September 5, 2000. The comment period is reopened and we will accept comments received on or before October 19, 2000. Any comments that are received after the closing date may not be considered in the final decision on this proposal.

ADDRESSES:

Copies of the draft economic analysis for the Great Lakes breeding population of piping plovers are available by writing to Piping Plover Information, U.S. Fish and Wildlife Service, Bishop Henry Whipple Federal Building, 1 Federal Drive, Fort Snelling, Minnesota 55111, on the Internet at http://www.fws.gov/pipingplover, or by calling (612) 713-5350. Written comments on the proposal for the Great Lakes breeding population should be sent to “Piping Plover Comments” at the above address, by e-mail to pipingplovercomments@fws.gov, or by facsimile to (612) 713-5292. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above Service address.

On July 6, 2000, the Service published a proposed rule to designate critical habitat for the Great Lakes breeding population of the piping plover in the Federal Register (65 FR 41812). The piping plover is a small, pale-colored North American shorebird. Its breeding range extends throughout the northern Great Plains, the Great Lakes, and the north Atlantic coast in the United States and Canada. Based on its distribution, three breeding populations of piping plover have been described: the Northern Great Plains population, the Great Lakes population, and the Atlantic Coast population. Although their breeding ranges are separate, their wintering ranges overlap and extend along the Atlantic and Gulf Coasts from southern North Carolina to Mexico and into the West Indies and the Bahamas. The Great Lakes breeding population is listed as endangered under the Endangered Species Act (Act) of 1973, as amended. We proposed a total of approximately 305 kilometers (km) (189 miles (m)) of Great Lakes mainland and island shoreline as critical habitat for this population of the piping plover. The proposed critical habitat is located in 27 counties in Minnesota, Wisconsin, Michigan, Illinois, Indiana, Ohio, Pennsylvania, and New York.

Section 4(b)(2) of the Act requires that the Secretary shall designate or revise critical habitat based upon the best scientific data available and after taking into consideration the economic impact of specifying any particular area as critical habitat. Based upon the previously published proposal to designate critical habitat for the Great Lakes breeding population of piping plovers, we have conducted a draft economic analysis of the proposed critical habitat designation. The draft economic analysis is available at the above Internet and mailing address. In order to accept the best and most current scientific data regarding the critical habitat proposal and the draft economic analysis of the proposal, we reopen the comment period at this time.

The Fish and Wildlife Service has previously conducted and recorded seven public hearings on this critical habitat proposal as required under Section 4(b)(5)(E) of the Act, as amended (16 U.S.C. 1531 et seq.). Due to the expeditious treatment of this proposed critical habitat determination under Federal District Court order as described in the proposed rule, we will not conduct additional hearings and will accept only written comments during the reopened comment period. Previously submitted oral or written comments on this critical habitat proposal need not be resubmitted.

The current comment period on this proposal closes on October 19, 2000. Written comments may be submitted to the Service office in the ADDRESSES section.

Author

The primary author of this notice is Laura Ragan (see ADDRESSES.)

Authority:

The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531-1544).

On August 18, 1999, Summit United Industries, Inc. (Summit) was convicted in the United States District Court for the Southern District of Texas, Houston Division, of violating the International Emergency Economic Powers Act (50 U.S.C.A. 1701-1706 (1991 & Supp. 2000)) (IEEPA). Specifically, Summit was convicted of aiding and abetting United States persons and others known and unknown to the United States Attorney of knowingly and willfully exporting, and causing to be exported, two sets of gear and shaft assemblies intended for use in a gear box used in an industrial turbine from the United States to Italy for ultimate delivery to WAHA, located in Tripoli, Libya, without the written authorization of the United States Government.

Section 11(h) of the Export Administration Act of 1979, as amended (currently codified at 50 U.S.C.A. app. 2401-2420 (1991 & Supp. 2000)) (the Act),1 provides that, at the discretion of the Secretary of Commerce,2 no person convicted of violating the IEEPA, or certain other provisions of the United States Code, shall be eligible to apply for or use any export license issued pursuant to, or provided by, the Act or the Export Administration Regulations (currently codified at 15 CFR parts 730-774 (2000), as amended (65 Fed. Reg. 14862, March 20, 2000)) (the Regulations), for a period of up to 10 years from the date of the conviction. In addition, any license issued pursuant to the Act in which such a person had any interest at the time of conviction may be revoked.

1 The Act expired on August 20, 1994. Executive Order 12924 (3 C.F.R., 1994 Comp. 917 (1995)), which has been extended by successive Presidential Notices, the most recent being that of August 3, 2000 (65 Fed. Reg. 48347, August 8, 2000), continued the Regulations in effect under the IEEPA.

2 Pursuant to appropriate delegations of authority that are reflected in the Regulations, the Director, Office of Exporter Services, in consultation with the Director, Office of Export Enforcement, exercises the authority granted to the Secretary by Section 11(h) of the Act.

Pursuant to sections 766.25 and 750.8(a) of the Regulations, upon notification that a person has been convicted of violating the IEEPA, the Director, Office of Exporter Services, in consultation with the Director, Office of Export Enforcement, shall determine whether to deny that person's export privileges for a period of up to 10 years from the date of conviction and shall also determine whether to revoke any license previously issued to such a person.

Having received notice of Summit's conviction for violating the IEEPA, and after providing notice and an opportunity for Summit to make a written submission to the Bureau of Export Administration before issuing an Order denying its export privileges, as provided in section 766.25 of the Regulations, I, following consultations with the Director, Office of Export Enforcement, have decided to deny Summit's export privileges for a period of five years from the date of its conviction. The five-year period ends on August 18, 2004. I have also decided to revoke all licenses issued pursuant to the Act in which Summit had an interest at the time of its conviction.

Accordingly, it is hereby Ordered

I. Until August 18, 2004, Summit United Industries, Inc., 6707 Sutter Park Lane, Houston, Texas 77066, may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States, that is subject to the Regulations, or in any other activity subject to the Regulations, including, but not limited to:

A. Applying for, obtaining, or using any license, License Exception, or export control document;

B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or

C. Benefiting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.

II. No person may, directly or indirectly, do any of the following:

A. Export or reexport to or on behalf of the denied person any item subject to the Regulations;

B. Take any action that facilitates the acquisition or attempted acquisition by the denied person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the denied person acquires or attempts to acquire such ownership, possession or control;

C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the denied person of any item subject to the Regulations that has been exported from the United States;

D. Obtain from the denied person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or

E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the denied person, or service any item, of whatever origin, that is owned, possessed or controlled by the denied person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.

III. After notice and opportunity for comment as provided in Section 766.23 of the Regulations, any person, firm, corporation, or business organization related to Summit by affiliation, ownership, control, or position of responsibility in the conduct of trade or related services may also be subject to the provisions of this Order.

IV. This Order does not prohibit any export, reexport, or other transaction subject to the Regulations where the only items involved that are subject to the Regulations are the foreign-produced direct product of U.S.-origin technology.

V. This Order is effective immediately and shall remain in effect until August 18, 2004.

VI. In accordance with Part 756 of the Regulation, Summit may file an appeal from this Order with the Under Secretary for Export Administration. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.

VII. A copy of this Order shall be delivered to Summit. This Order shall be published in the Federal Register.

On December 13, 1999, the Department of Commerce (“the Department”) initiated a changed circumstances review, in response to a request from Micron Technology Inc. (“the petitioner”), to determine whether Hyundai MicroElectronics Co., Ltd. (“Hyundai MicroElectronics”), is the successor-in-interest to LG Semicon Co., Ltd., (“LG Semicon”) and Hyundai Electronics Industries Co., Ltd., (“Hyundai”). The Department is rescinding this review after receiving a withdrawal from the petitioner of its request for review.

Unless otherwise indicated, all citations to the Tariff Act of 1930, as amended (“the Act”), are references to the provisions effective January 1, 1995, the effective date of the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations at 19 CFR Part 351 (1999).

Background

On November 12, 1999, the petitioner requested that the Department conduct a changed circumstances review to determine the cash deposit rate to be applied to Hyundai MicroElectronics in light of the acquisition of LG Semicon by Hyundai, two companies subject to the antidumping duty order.

On December 13, 1999, the Department published in the Federal Register (64 FR 69492) a notice of initiation of a changed circumstances review. On August 14, 2000, the petitioner requested that it be allowed to withdraw its request for review.

Rescission of Review

The Department is rescinding this review because the requesting party withdrew its request and there are no compelling reasons to continue the review. See Brass Sheet and Strip From Canada; Termination of Antidumping Duty Administrative Review, 63 FR 23269 (April 28, 1998). We note that LG Semicon and Hyundai currently have the same cash deposit rate and that the acquisition of LG Semicon by Hyundai took place in October 1999. Therefore, we will address the acquisition in the context of the May 1, 1999 through April 30, 2000 administrative review of DRAMs from Korea.

This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.105(a). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulation and the terms of an APO is a sanctionable violation.

This notice is in accordance with section 771(i) of the Act and of 19 CFR 351.216.

Comments: None received. Decision: Approved. No instrument of equivalent scientific value to the foreign instrument, for such purposes as it is intended to be used, is being manufactured in the United States. Reasons: The foreign instrument provides picking of clones containing DNA of interest from subclone libraries of bacterial artificial chromosomes with a picking rate of 3500 clones per hour and gridding of 100,000 samples per hour. The National Institutes of Health advises in its memorandum of August 10, 2000 that (1) this capability is pertinent to the applicant's intended purpose and (2) it knows of no domestic instrument or apparatus of equivalent scientific value to the foreign instrument for the applicant's intended use.

We know of no other instrument or apparatus of equivalent scientific value to the foreign instrument which is being manufactured in the United States.

The Office of Export Trading Company Affairs (“OETCA”), International Trade Administration, Department of Commerce, has received an application to amend an Export Trade Certificate of Review (“Certificate”). This notice summarizes the proposed amendment and requests comments relevant to whether the Certificate should be issued.

FOR FURTHER INFORMATION CONTACT:

Morton Schnabel, Director, Office of Export Trading Company Affairs, International Trade Administration, (202) 482-5131 (this is not a toll-free number) or E-mail at oetca@ita.doc.gov.

SUPPLEMENTARY INFORMATION:

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from state and federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the Federal Register identifying the applicant and summarizing its proposed export conduct.

Request for Public Comments

Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked privileged or confidential business information will be deemed to be nonconfidential. An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Office of Export Trading Company Affairs, International Trade Administration, Department of Commerce, Room 1104H, Washington, D.C. 20230. Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 87-15A04.”

Notice, correction; notice of procedures and start date for the Safe Harbor List.

SUMMARY:

This document contains corrections to the final documents which were published in the Federal Register on July 24, 2000 (65 FR 45666), relating to the safe harbor privacy framework and the procedures and start date for U.S. organizations to sign up to the safe harbor list. The corrected document and procedures and start date of the safe harbor list can also be found on the International Trade Administration's website (www.ita.doc.gov/ecom).

DATES:

This correction is effective immediately. The start date for the safe harbor is November 1, 2000.

Background

The final safe harbor privacy principles, Frequently Asked Questions, and related documents were formally issued on July 21, 2000. On July 27, 2000, The European Commission adopted a Decision determining that safe harbor arrangement provides adequate protection for personal data transferred from the EU. Several changes and additional information follow on how U.S. organizations may sign up to the safe harbor list.

FOR FURTHER INFORMATION CONTACT:

Further information on the safe harbor can be found at www.ita.doc.gov/ecom or by calling the Department of Commerce at 202-482-1614.

Correction of Publication

The publication of the final safe harbor privacy framework as published at 65 FR 45666 is corrected as follows:

Safe Harbor Privacy Principles Issued by the U.S. Department of Commerce on July 21, 2000:

In paragraph 4, the last sentence should read: “For the same reason, where the option is allowable under the Principles and/or U.S. law, organizations are expected to opt for the higher protection where possible.”

Beginning Date of the Safe Harbor List

U.S. organizations may begin signing up to the safe harbor list at www.ita.doc.gov/ecom beginning November 1, 2000. Organizations may either input information into the website or they may send a letter to the Department of Commerce, Attention: Safe Harbor Registration, Room 2009, Washington, DC 20230.

Signing up to the list:

• To be included on the safe harbor list, organizations must notify the Department of Commerce that they adhere to the safe harbor privacy principles developed by the Department of Commerce in coordination with the European Commission. The principles provide guidance for U.S. organizations on how to provide “adequate protection” for personal data from Europe as required by the European Union's Directive on Data Protection.

• An organization's request to be put on the safe harbor list, and its appearance on this list pursuant to that request, constitute a representation that it adheres to a privacy policy that meets the safe harbor privacy principles. Organizations must also publicly declare and state in their privacy policies that they adhere to the safe harbor principles.

• Adherence to the safe harbor principles and subscription to the list are entirely voluntary. An organization's absence from the list does not mean that it does not provide effective protection for personal data or that it does not qualify for the benefits of the safe harbor.

• In order to keep this list current, a notification will be effective for a period of twelve months. Therefore, organizations need to notify the Department of Commerce every twelve months to reaffirm their continued adherence to the safe harbor principles.

• Organizations should notify the Department of Commerce if their representation to the Department is no longer valid. Failure by an organization to so notify the Department could constitute a misrepresentation of its adherence to the safe harbor privacy principles and failure to do so may be actionable under the False Statements Act (18 U.S.C. § 1001).

• An organization may withdraw from the list at any time by notifying the Department of Commerce. Withdrawal from the list terminates the organization's representation of adherence to the safe harbor principles, but this does not relieve the organization of its obligations with respect to personal information received prior to the termination.

• If a relevant self-regulatory or government enforcement body finds an organization has engaged in a persistent failure to comply with the principles, then the organization is no longer entitled to the benefits of the safe harbor.

• In order to sign up to the list, organizations may either send a letter signed by a corporate officer to the Department of Commerce or have a corporate officer register on the Department of Commerce's website (www.ita.doc.gov) that provides all information required in FAQ 6.

• In maintaining the list, the Department of Commerce does not assess and makes no representation as to the adequacy of any organization's privacy policy or its adherence to that policy. Furthermore, the Department of Commerce does not guarantee the accuracy of the list and assumes no liability for the erroneous inclusion, misidentification, omission, or deletion of any organization, or any other action related to the maintenance of the list.

This notice advises other agencies and the public that I.P. Pacific has submitted applications to the Fish and Wildlife Service and the National Marine Fisheries Service (collectively, the Services) for Incidental Take Permits (Permits) pursuant to the Endangered Species Act of 1973, as amended (Act). As required by the Act, I.P. Pacific has also prepared a draft Habitat Conservation Plan (HCP) intended to minimize and mitigate any such take of endangered or threatened species. The Permit applications are related to forest land management and timber harvest on 28,388 acres of I.P. Pacific’s lands within the Yakama Indian Reservation, located in Yakima and Klickitat Counties, WA.

The Permit applications include the draft HCP and the draft Implementing Agreement. The Services also announce the availability of a draft Environmental Assessment (EA) for the Permit applications. The draft EA and HCP have been combined in a single document with the HCP as the Proposed Action Alternative, Alternative B, termed the Multi-species HCP Alternative.

This notice is provided pursuant to the Act and National Environmental Policy Act (NEPA) regulations. The Services are furnishing this notice in order to allow other agencies and the public an opportunity to review and comment on these documents. All comments received will become part of the public record and will be available for review pursuant to the Act.

DATES:

Written comments on the permit applications, draft EA, HCP, and Implementing Agreement must be received no later than November 20, 2000.

ADDRESSES:

Requests for documents on CD ROM should be made by calling the Fish and Wildlife Service at (360) 534-9330. Hardbound copies are also available for viewing, and partial or complete duplication (see SUPPLEMENTARY INFORMATION, under the heading Libraries).

The documents may also be viewed electronically on the World Wide Web at the Fish and Wildlife Service Region 1 HCP Home Page: http://pacific.fws.gov/hcp.

Section 9 of the Act and Federal regulations prohibit the “taking” of a species listed as endangered or threatened. The term “take” is defined under the Act to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. Harm is defined to include significant habitat modification or degradation where it actually kills or injures wildlife by significantly impairing essential behavioral patterns, including breeding, spawning, rearing, migrating, feeding, or sheltering.

The Services may issue permits, under limited circumstances, to take listed species incidental to, and not the purpose of, otherwise lawful activities. Fish and Wildlife Service regulations governing permits for endangered species are promulgated in 50 CFR 17.22 and, regulations governing permits for threatened species are promulgated in 50 CFR 17.32. National Marine Fisheries Service regulations governing permits for threatened and endangered species are promulgated in 50 CFR 222.307.

I.P. Pacific owns and manages scattered parcels throughout the upper Klickitat River Basin. The portion of these lands located within the Yakama Indian Reservation are being considered by the Services for coverage under section 10(a) of the Act. I.P. Pacific’s ownership proposed for coverage totals 28,388 acres, located near the southwest corner of Yakima County near the town of Glenwood, WA. Proposed management activities include timber harvest and general forest management. Some timber harvest and forest management activities have the potential to affect species subject to protection under the Act. Section 10 of the Act contains provisions for the issuance of permits to non-federal land owners for the take of endangered and threatened species, provided the take is incidental to otherwise lawful activities, and will not appreciably reduce the likelihood of the survival and recovery of the species in the wild. In addition, the applicant must prepare and submit to the Services for approval an HCP containing a strategy for minimizing and mitigating all take associated with the proposed activities to the maximum extent practicable. The applicant must also ensure that adequate funding for the HCP will be provided.

I.P. Pacific has developed the draft HCP with technical assistance from the Services to obtain the Permits for their activities on land under their ownership within the boundaries of the Yakama Indian Reservation. Activities proposed for Permit coverage include the following: harvest of trees; silvicultural treatments; site preparation; tree planting; timberland inventory and monitoring; construction, maintenance, and use of logging roads and landings; quarrying stone and gravel; fire prevention and suppression; habitat restoration; use of low-flying aircraft; tribal access; and, aerial spraying of the biological pesticide Bt (Bacillus thuringiensis) to control spruce budworm. Clear-cutting of timber will be minimized and used only where necessary to restore sustainable stands. The Permits also propose to cover certain monitoring activities and fish and wildlife surveys within the Plan area.

Federal guidelines regarding tribal trust responsibilities and government-to-government relations with the Yakama Tribe are being closely followed by the Services. The Yakama Tribal Council, Timber Program, and Resources Offices have been consulted throughout the Plan development process to the greatest extent possible. The following three alternatives are currently analyzed in detail in the draft EA: (A) the No Action Alternative; (B) the Proposed Plan Alternative, titled the Multi-species HCP Alternative; and, (C) the Spotted Owl Only Alternative. Under Alternative A, the No Action Alternative, no permit would be issued, take would be avoided for all threatened and endangered species on the property, and Yakama Indian Nation guidelines for protection of riparian areas would be followed. Alternative B, the Multi-species HCP Alternative, involves issuing a Permit authorizing take of seven threatened and endangered species on the property, with provisions for authorizing take for 30 unlisted species in the future should they be listed during the term of the Permits. The Plan details minimization and mitigation measures for these threatened, endangered, and unlisted species. Alternative C, the Spotted Owl Only Alternative, involves the Fish and Wildlife Service issuing a permit for the northern spotted owl only, and I.P. Pacific would continue to follow the Yakama Indian Nation guidelines for protection of riparian areas, as in the No Action Alternative.

Alternatives considered during scoping but which were not analyzed in detail include a Historical Forest Restoration Alternative, a Washington State Forest and Fish Agreement Alternative, an Expanded Covered Species Alternative, and a Northwest Forest Plan Alternative. These four alternatives were not analyzed in detail because they did not meet the stated purpose and needs of the proposed action, which are to provide protection and conservation to listed and proposed species and their habitats to the extent intended under section 10(a)(1)(B) of the Act, while allowing I.P. Pacific to fulfill its forest management and timber harvest planning in a practical manner.

This notice is provided pursuant to section 10(a) of the Act and NEPA regulations. The Services will evaluate the applications, associated documents, and comments submitted thereon to determine whether the application meets the requirements of the Act and NEPA. If it is determined that the requirements are met, a permit will be issued for the incidental take of all covered species. The final permit decisions will be made no sooner than November 20, 2000.

Roy Unger, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212. For information on the quota status of these limits, refer to the Quota Status Reports posted on the bulletin boards of each Customs port, call (202) 927-5850, or refer to the U.S. Customs website at http://www.customs.gov. For information on embargoes and quota re-openings, call (202) 482-3715.

SUPPLEMENTARY INFORMATION: Authority:

Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.

In a notice and letter to the Commissioner of Customs published in the Federal Register on May 12, 2000 (65 FR 30571), the Government of the United States increased the limits for all quota categories as a result of the Royal Government of Cambodia's progress in improving working conditions in the Cambodian textile and apparel industries through increased compliance with internationally recognized core labor standards through the application of Cambodian labor law. The limits are being increased further because of Cambodia's continued efforts in this area.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 64 FR 71982, published on December 22, 1999). Also see 64 FR 70217, published on December 16, 1999.

Richard B. Steinkamp, Acting Chairman, Committee for the Implementation of Textile Agreements.Committee for the Implementation of Textile Agreements September 14, 2000. Commissioner of Customs, Department of the Treasury, Washington, DC 20229.

Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on December 10, 1999. That directive concerns imports of certain cotton, wool and man-made fiber textile products, produced or manufactured in Cambodia and exported during the twelve-month period which began on January 1, 2000 and extends through December 31, 2000.

Effective on September 19, 2000, you are directed to increase the current limits for the following categories, as provided for under the terms of the current bilateral textile agreement between the Governments of the United States and Cambodia:

Naomi Freeman, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212. For information on the quota status of these limits, refer to the Quota Status Reports posted on the bulletin boards of each Customs port, call (202) 927-5850, or refer to the U.S. Customs website at http://www.customs.gov. For information on embargoes and quota re-openings, call (202) 482-3715.

SUPPLEMENTARY INFORMATION: Authority:

Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.

The current limits for certain categories are being adjusted for carryover, swing and the recrediting of unused carryforward.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 64 FR 71982, published on December 22, 1999). Also see 64 FR 54868, published on October 8, 1999.

Richard B. Steinkamp, Acting Chairman, Committee for the Implementation of Textile Agreements.Committee for the Implementation of Textile Agreements September 14, 2000. Commissioner of Customs, Department of the Treasury, Washington, DC 20229.

Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on October 4, 1999, by the Chairman, Committee for the Implementation of Textile Agreements. That directive concerns imports of certain cotton, wool and man-made fiber textile products, produced or manufactured in Guatemala and exported during the period which began on January 1, 2000 and extends through December 31, 2000.

Effective on September 20, 2000, you are directed to adjust the current limits for the following categories, as provided for under the Uruguay Round Agreement on Textiles and Clothing:

Ross Arnold, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212. For information on the quota status of these limits, refer to the Quota Status Reports posted on the bulletin boards of each Customs port, call (202) 927-5850, or refer to the U.S. Customs website at http://www.customs.gov. For information on embargoes and quota re-openings, call (202) 482-3715.

SUPPLEMENTARY INFORMATION: Authority:

Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.

The current limits for certain categories are being adjusted for swing, special swing, special shift, carryover, carryforward and the recrediting of unused carryforward.

A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 64 FR 71982, published on December 22, 1999). Also see 64 FR 62657, published on November 17, 1999.

Richard Steinkamp, Acting Chairman, Committee for the Implementation of Textile Agreements.Committee for the Implementation of Textile Agreements September 14, 2000. Commissioner of Customs, Department of the Treasury, Washington, DC 20229.

Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on November 8, 1999, by the Chairman, Committee for the Implementation of Textile Agreements. That directive concerns imports of certain cotton, wool and man-made fiber textiles and textile products and silk blend and other vegetable fiber apparel, produced or manufactured in Malaysia and exported during the period beginning on January 1, 2000 and extending through December 31, 2000.

Effective on September 19, 2000, you are directed to adjust the limits for the following categories, as provided for under the Uruguay Round Agreement on Textiles and Clothing:

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of P.L. 104-614 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-62 with attached transmittal and policy justification.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-63 with attached transmittal and policy justification.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of P.L. 104-164 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-67 with actual transmittal, policy justification, and Sensitivity of Technology.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-66 with attached transmittal, policy justification, and Sensitivity of Technology.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-64 with attached transmittal, policy justification, and Sensitivity of Technology.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Pub. L. 104-164 dated 21 July 1996.

FOR FURTHER INFORMATION CONTACT:

Ms. J. Hurd, DSCA/COMPT/RM, (703) 604-6575.

The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 00-65 with attached transmittal, policy justification, and Sensitivity of Technology.

The Ballistic Missile Defense Advisory Committee (BMDAC) has been renewed in consonance with the public interest, and in accordance with the provisions of Public Law 92-463, the “Federal Advisory Committee Act.”

The BMDAC provides the Director, Ballistic Missile Defense Organization and the Secretary of Defense with advice and insights into the ballistic missile defense program, and makes recommendations on the program emphasis, schedule and content. The BMDAC assesses all matters relating to acquisition system development, and technology for defense against ballistic missile threat.

The Committee will continue to be composed of 15-20 leaders from government and the private sector who are recognized authorities in defense policy, acquisition and technical areas related to the ballistic missile defense program. Efforts will be made to ensure that there is a fairly balanced membership in terms of the functions to be performed and the interest groups represented.

The DFAS Board of Advisors is being established in consonance with the public interest and in accordance with the provisions of Pub. L. 92-463, the “Federal Advisory Committee Act,” Title 5 U.S.C., Appendix 2.

This advisory committee will provide advice and recommendations to the Secretary of Defense and Deputy Secretary of Defense regarding the streamlining and modernization of DFAS as it transforms its financial management operations, processes and systems. Goals include making the organization as effective and economical as feasible, responsive to the needs of decision makers, compliant with statutes, safeguarded against fraud and abuse and a leader in customer service. The Board will make recommendations concerning the best allocation and expenditure of funds and the speed and shape of DFAS reform.

The DFAS Board of Advisors will consist of a balanced membership of approximately ten senior executives and flag rank military officers, as well as several representatives from the private sector appointed by the Secretary of Defense.

Pursuant to Public Law 92-463, notice is hereby given of a forthcoming meeting of the Group of Advisors to the National Security Education Board. The purpose of the meeting is to review and make recommendations to the Board concerning requirements established by the David L. Boren National Security Education Act, Title VIII of Public Law 102-183, as amended.

Office of the Deputy Under Secretary of Defense (Environmental Security).

ACTION:

Notice of availability.

SUMMARY:

Notice is hereby given of the release of the DoD Interim Policy on Land Use Controls Associated with Environmental Restoration Activities. This policy, signed on August 31, 2000, by Ms. Sherri Goodman, Deputy Under Secretary of Defense (Environmental Security), provides an overall DoD framework for implementing, documenting, and managing land use controls (LUCs) for real property that is transferred out of Federal control and for active installations. The policy is available in the Publications section of the DoD Environmental Cleanup Homepage on the World Wide Web. The internet address for the homepage is http://www.dtic.mil/envirodod/.

The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.

DATES:

Interested persons are invited to submit comments on or before November 20, 2000.

SUPPLEMENTARY INFORMATION:

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Abstract: For the past two years, the federal government has supported an effort to promote the hiring of high quality teachers to reduce the size of classrooms in the early elementary grades. This evaluation looks at the early implementation of the program and assesses how the federal class size reduction (CSR) funds were spent, what issues arose in implementing the program, the impact of the program on class size, and the impact of the program on teaching.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651. Requests may also be electronically mailed to the internet address OCIO_IMG_Issues@ed.gov or faxed to 202-708-9346.

Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Jacqueline Montague at (202) 708-5359 or via her internet address Jackie_Montague@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

DOE has issued a Final Environmental Impact Statement for the Treatment and Management of Sodium-Bonded Spent Nuclear Fuel (final EIS) (Notice of Availability, 65 FR 47987, August 4, 2000) (DOE/EIS-0306, July 2000). After careful consideration of public comments on the draft EIS and programmatic, environmental, nonproliferation, and cost issues, DOE has decided to implement the preferred alternative identified in the final EIS. That is, DOE has decided to electrometallurgically treat the Experimental Breeder Reactor-II (EBR-II) spent nuclear fuel (about 25 metric tons of heavy metal) and miscellaneous small lots of sodium-bonded spent nuclear fuel. The fuel will be treated at Argonne National Laboratory-West (ANL-W). Because of the different physical characteristics of the Fermi-1 sodium-bonded blanket spent nuclear fuel (about 34 metric tons of heavy metal), DOE has decided to continue to store this material while alternative treatments are evaluated. Should no alternative prove more cost effective for this spent nuclear fuel, electrometallurgical treatment (EMT) of the Fermi-1 spent nuclear fuel remains a key option.

ADDRESSES:

The final EIS and this ROD are available on the Office of Environment, Safety and Health National Environmental Policy Act (NEPA) home page at http://www.tis.eh.doe.gov/nepa/ or on the Office of Nuclear Energy, Science and Technology home page at http://nuclear.gov. You may request copies of the final EIS and this ROD by calling the toll-free number 1-877-450-6904, by faxing requests to 1-877-621-8288, via electronic mail to sodium.fuel.eis@hq.doe.gov, or via mail to: Susan Lesica, Document Manager, Office of Nuclear Energy, Science and Technology, NE-40, U.S. Department of Energy, 19901 Germantown Road, Germantown, Maryland 20874.

FOR FURTHER INFORMATION CONTACT:

For information on the alternative strategies for the treatment and management of sodium-bonded spent nuclear fuel, contact Susan Lesica at the address listed above. For general information on the DOE NEPA process, please contact: Carol Borgstrom, Director, Office of NEPA Policy and Compliance (EH-42), U.S. Department of Energy, 1000 Independence Avenue, S.W., Washington, D.C. 20585, (202) 586-4600, or leave a message at 1-800-472-2756.

SUPPLEMENTARY INFORMATION:I. Background

For nearly four decades, research, development, and demonstration activities associated with liquid metal fast breeder reactors were conducted at EBR-II, about 40 miles west of Idaho Falls, Idaho; the Enrico Fermi Atomic Power Plant (Fermi-1) in Monroe, Michigan; and the Fast Flux Test Facility at the Hanford Site in Richland, Washington. These activities generated approximately 60 metric tons of heavy metal of sodium-bonded spent nuclear fuel for which DOE is now responsible for safe management and disposition.

Sodium-bonded spent nuclear fuel is distinguished from other nuclear reactor spent nuclear fuel by the presence of metallic sodium (a highly reactive material), metallic uranium and plutonium (which are also potentially reactive), and in some cases, highly enriched uranium. Metallic sodium in particular presents challenges for management and ultimate disposal of this spent nuclear fuel. Metallic sodium reacts with water to produce explosive hydrogen gas and corrosive sodium hydroxide that would likely not be acceptable for geologic disposal.

DOE's sodium-bonded spent nuclear fuel is of two general types: driver fuel and blanket fuel. Driver fuel is used mainly in the center of the reactor core to “drive” and sustain the fission chain reaction. Blanket fuel is usually placed at the outer perimeter of the core and is used to breed plutonium-239, a fissile material, and for shielding. The blanket and driver fuel addressed in this ROD contain metallic sodium between the cladding (outer layer) and the metallic fuel pins to improve heat transfer from the fuel to the reactor coolant through the cladding. When the driver fuel is irradiated for some period of time, the metallic fuel swells as fission products are generated until it reaches the cladding wall. During this process, metallic sodium enters the metallic fuel and becomes inseparable from it. In addition, fuel and cladding components interdiffuse to such an extent that mechanical stripping of the driver spent nuclear fuel cladding is not a practical means of removing the sodium. On the other hand, when blanket fuel is irradiated, the metallic fuel does not swell to the same degree as the driver fuel because less fission occurs, producing fewer fission products (i.e., lower “burnup”). As a result, minimal metallic sodium enters the fuel and there is no interdiffusion between the fuel and cladding. This allows mechanical stripping of the blanket spent nuclear fuel cladding. Because of these differences between irradiated driver fuel and blanket fuel, there are different treatment alternatives for each fuel type.

There are approximately 60 metric tons of heavy metal in the DOE's inventory of sodium-bonded spent nuclear fuel. The inventory includes 25 metric tons of heavy metal of fuel from EBR-II, of which three metric tons of heavy metal are driver fuel and 22 metric tons of heavy metal are blanket fuel. EBR-II fuel is stainless steel clad and is stored at the Idaho National Engineering and Environmental Laboratory (INEEL). The EBR-II driver fuel contains highly enriched uranium in a uranium alloy, typically either zirconium or fissium (an alloy of molybdenum, ruthenium, rhodium, palladium, zirconium, and niobium). The EBR-II blanket fuel contains depleted uranium in metallic form. Approximately 34 metric tons of heavy metal are blanket fuel from the Fermi-1 reactor and are stored at INEEL. This blanket fuel consists of stainless steel-clad, depleted uranium in a uranium-molybdenum alloy. Fermi-1 blanket elements are similar to EBR-II blanket elements in enrichment but differ in dimensions (Fermi-1 elements are larger), form (Fermi-1's uranium-molybdenum alloy versus EBR-II's uranium metal), and burnup. Because of its lower burnup, the Fermi-1 blanket fuel, which contains only about 0.2 percent plutonium by weight compared to approximately 1 percent plutonium by weight for the EBR-II blanket fuel, is subject to less stringent safeguard and security requirements than the EBR-II blanket fuel. This is an important consideration in the cost of storing these two fuel types.

The remainder of the DOE's sodium-bonded spent nuclear fuel inventory consists of small lots of miscellaneous sodium-bonded fuel, with a combined weight of approximately 400 kilograms of heavy metal (or 0.4 metric tons of heavy metal). Three hundred kilograms of this miscellaneous fuel are from liquid metal reactor test assemblies containing driver fuel that were irradiated at the Fast Flux Test Facility. The remaining 100 kilograms of heavy metal are small quantities of fuel from liquid metal reactor experiments that have metallic sodium or an alloy of sodium and potassium. These fuels differ in cladding composition, uranium content, enrichment, and burnup. Some of the fuel consists of uranium and/or plutonium carbides, nitrides, and oxides in addition to metal uranium or uranium alloy. This fuel is stored at several DOE sites, including the Hanford Site, Oak Ridge National Laboratory, Savannah River Site (SRS), Sandia National Laboratories, and INEEL. Those lots stored outside INEEL will be transported to INEEL pursuant to the Record of Decision (60 FR 28680, June 1, 1995) for the Programmatic Spent Nuclear Fuel EIS (DOE/EIS-0203, April 1995).

Before electrometallurgical treatment could be considered as a technology choice for treating EBR-II spent nuclear fuel, an appropriate demonstration project was needed to evaluate its technical feasibility. As a preliminary step to demonstration, DOE requested that the National Research Council conduct an independent assessment of electrometallurgical treatment technology and its potential application to EBR-II spent nuclear fuel. In its report, published in 1995, the National Research Council recommended that DOE proceed with demonstrating the technical feasibility of electrometallurgical treatment using a fraction of the EBR-II spent nuclear fuel. DOE then conducted an environmental assessment of the demonstration project. The environmental assessment was completed in May 1996 and resulted in a Finding of No Significant Impact. In June 1996, DOE initiated a three-year testing program at ANL-W to demonstrate the technical feasibility of electrometallurgical treatment of up to 100 EBR-II driver spent nuclear fuel assemblies and up to 25 EBR-II blanket spent nuclear fuel assemblies. The two types of EBR-II spent nuclear fuel, driver and blanket, are typical of most of DOE's sodium-bonded spent nuclear fuel.

Working with DOE and the National Research Council review committee, ANL-W established four criteria for evaluating the demonstration. Upon completion of the demonstration, all key performance criteria were met or exceeded, proving the technical feasibility of using electrometallurgical treatment technology to treat sodium-bonded spent nuclear fuel. In addition, the demonstration project validated the throughput rate of the sodium-bonded spent nuclear fuel, quantified all process streams, fine-tuned the operational parameters, refined the electrometallurgical treatment equipment, and provided actual waste forms for characterization.

DOE is now at the point of deciding how to manage the sodium-bonded spent nuclear fuel to facilitate its ultimate disposal in a geologic repository. The reasonable alternatives for this proposed action are predicated on the technology options available to DOE. There is some risk in implementing any alternative in that the resultant waste form may still not be acceptable for disposal in a geologic disposal. DOE currently is studying Yucca Mountain in Nevada as a potential site for development of a geologic repository. Under current schedules, final waste acceptance criteria would not be available until about 2005, and then only if a decision has been made to proceed with development of a repository at Yucca Mountain and the Nuclear Regulatory Commission issues a licence to construct the repository. The preliminary waste acceptance criteria for Yucca Mountain are used as a basis for planning treatment of the sodium-bonded spent nuclear fuel.

Currently, more than 98 percent of DOE's sodium-bonded spent nuclear fuel is located at INEEL, near Idaho Falls, Idaho. DOE committed to remove all spent nuclear fuel from Idaho by 2035 in a 1995 agreement with the State of Idaho (Settlement Agreement and Consent Order issued on October 17, 1995, in the actions of Public Service Co. of Colorado v. Batt, No. CV 91-0035-S-EJL [D. Id.], and United States v. Batt, No. CV 91-0054-EJL [D. Id.]). Before sodium-bonded spent nuclear fuel can be removed from the State of Idaho for ultimate disposal, some or all of the fuel may require treatment.

Purpose and Need for Agency Action

Sodium-bonded spent nuclear fuel contains metallic sodium that was used as a heat-transfer medium within the stainless steel cladding (outer layer) of the nuclear fuel. While sodium has been removed from the fuel's external surface, some sodium remains bonded to the uranium metal alloy fuel within the cladding and cannot be removed without further treatment. This sodium could complicate compliance with the eventual final repository waste acceptance criteria. Metallic sodium reacts vigorously with water, producing heat, potentially explosive hydrogen gas, and sodium hydroxide, a corrosive substance. Sodium is also pyrophoric (i.e., susceptible to spontaneous ignition and continuous combustion). Most (i.e., 99 percent by weight) of the sodium-bonded spent nuclear fuel contains metallic uranium and plutonium. These metals are reactive in the presence of air and moisture. The Yucca Mountain preliminary waste acceptance criteria exclude reactive and potentially explosive materials beyond trace quantities. Additionally, some of the sodium-bonded spent nuclear fuel contains highly enriched uranium that could create criticality (that is, a self-sustained nuclear chain reaction) concerns requiring control methods.

To ensure that the terms of the State of Idaho Settlement Agreement and Consent Order are met and to facilitate disposal, DOE needs to reduce the uncertainties associated with qualifying sodium-bonded spent nuclear fuel for disposal. Treating the sodium-bonded spent nuclear fuel could make it significantly easier to dispose of the fuel. In addition, DOE could significantly reduce the safeguard and security costs associated with long-term storage of the EBR-II blanket spent nuclear fuel, due to its high plutonium content, by treating the fuel. Furthermore, delaying the implementation of this decision could result in a loss of capability and of technical staff knowledgeable about and experienced with the demonstration project. This was an important consideration in the decision to proceed with this NEPA review.

NEPA Process

On February 22, 1999, DOE published in the Federal Register a Notice of Intent to prepare an Environmental Impact Statement for Electrometallurgical Treatment of Sodium-Bonded Spent Nuclear Fuel in the Fuel Conditioning Facility at Argonne National Laboratory-West (64 FR 8553). During the 45-day scoping period, DOE received 228 comments on the proposed scope of the EIS via mail, telephone, facsimile, and during the four public scoping meetings. DOE considered these comments and, as a result, changed the proposed action of the EIS as well as the structure of the alternatives. The proposed action was changed from electrometallurgical treatment of sodium-bonded spent nuclear fuel at the Fuel Conditioning Facility at ANL-W to the treatment and management of sodium-bonded spent nuclear fuel. This change was made to address concerns about bias for one treatment technology over others. The alternatives were restructured to reflect differences in the characteristics of the sodium-bonded spent nuclear fuel types. Thus, several alternatives were added that treat blanket and driver spent nuclear fuel by different technologies.

In July 1999, DOE published the Draft Environmental Impact Statement for the Treatment of Sodium-Bonded Spent Nuclear Fuel. The 45-day comment period began on July 31, 1999, and was scheduled to end on September 13, 1999. In response to commentor requests, the comment period was extended an additional 15 days through September 28, 1999. Four public hearings were held during the comment period. A total of 494 comments were received and considered, and responses can be found in the final EIS, which was issued in July 2000. Most of these comments focused on the following issues: (1) The purpose, need for, and timing of the proposed action; (2) new waste forms produced by the proposed action, their acceptability in a geologic repository, and the disposition of uranium and plutonium by-products; (3) the public availability of information considered relevant to reviewing the draft EIS; (4) the cost of the various alternatives; (5) the impacts of the proposed action on U.S. nuclear nonproliferation policy; (6) technical or NEPA-related issues regarding technologies and alternatives; and (7) issues related to the affected environment and the environmental consequences. Volume 2, Section A.2 of Appendix A of the final EIS provides an overview of the public hearings and DOE's responses to all comments. No comments have been received on the final EIS.

II. Treatment Technology Options EMT Process

The EMT process uses electrorefining, an industrial technology used to produce pure metals from impure metal feedstock. Electrorefining has been used to purify metal for more than 100 years. The electrometallurgical process for treatment of EBR-II blanket and driver spent nuclear fuel assemblies containing metallic fuel was developed at Argonne National Laboratory. The process has been demonstrated for the stainless steel clad uranium alloy fuel used in EBR-II. Modifications to the process could be used for the treatment of oxide, nitride, and carbide sodium-bonded spent nuclear fuel. The fuel would be chopped, placed in molten salt, and electrorefined. After electrorefining, the molten salt, fission products, sodium, and transuranics, including plutonium, would be removed from the electrofiner, mixed with a filter and ion-exchange agent known as zeolite, and heated so the salt becomes sorbed into the zeolite structure. Glass powder then would be added to the zeolite mixture and consolidated to produce a ceramic high-level radioactive waste form. The uranium would be removed, melted (and depleted uranium would be added, if necessary), and processed in a metal casting furnace to produce low-enriched or depleted uranium ingots. The ingots would be stored until a disposition decision is made through a separate NEPA review. The stainless steel cladding hulls and the insoluble fission products would be melted in the casting furnace to produce a metallic high-level radioactive waste form.

Plutonium Uranium Extraction (PUREX) Process

The PUREX process has been used extensively throughout the world since 1954 to separate and purify uranium and plutonium from fission products contained in spent nuclear fuel and irradiated uranium targets. It is a chemical separation process that uses aqueous solvent extraction to perform the separation. DOE has two operating facilities at the SRS, F-Canyon and H-Canyon, that use the PUREX process. Use of these facilities for treating sodium-bonded spent nuclear fuel involves certain restrictions inherent in the design: (1) The sodium complicates the process as employed in the SRS facilities; (2) the stainless steel cladding would require significant modifications or additions to the existing facilities; and (3) the presence of alloys (e.g., zirconium) is incompatible with the SRS dissolution process. For this reason, treatment of driver sodium-bonded spent nuclear fuel is not feasible without significant modification to the existing PUREX process. However, the F-Canyon facility could be used without modifications for the blanket sodium-bonded spent nuclear fuel if the spent nuclear fuel were declad and the sodium were removed prior to the process.

After processing, the following would be produced: (1) An aqueous high-level radioactive waste containing the bulk of the fission products, americium, and neptunium; (2) a material stream containing the recovered plutonium (as plutonium metal); and (3) a material stream containing the recovered uranium (as uranium oxide). The aqueous high-level radioactive waste would be processed to a borosilicate glass form. The uranium oxide would be stored on site as depleted uranium. The plutonium would be disposed of in accordance with the ROD (65 FR 1608, January 11, 2000) for the Surplus Plutonium Disposition Final Environmental Impact Statement (DOE/EIS-0283, November 1999).

High-Integrity Can Packaging

High-integrity can packaging would provide substitute cladding for damaged or declad fuel and another level of containment for intact fuel. The can is constructed of a highly corrosion-resistant material to provide corrosion protection during storage. The high-integrity cans are placed into standardized canisters that are ready for disposal in waste packages. High-integrity cans would be used to store the sodium-bonded spent nuclear fuel on site until it can be shipped to a repository.

The EIS analysis for packaging sodium-bonded spent nuclear fuel in high-integrity cans was performed with and without decladding and/or sodium removal. Packaging sodium-bonded blanket spent nuclear fuel in high-integrity cans with sodium removal was analyzed in the EIS under Alternative 2. Packaging sodium-bonded spent nuclear fuel in high-integrity cans without sodium removal was considered in the EIS as a direct disposal option under the No Action Alternative. The high-integrity cans would be placed in dry storage at ANL-W. They would be placed into a standardized canister for transportation and eventual placement in waste packages in a geologic repository.

Melt and Dilute Process

The melt and dilute process involves chopping and melting the spent nuclear fuel and diluting it by adding depleted uranium or other metals. There are three options for the melt and dilute process that are applicable to sodium-bonded spent nuclear fuel. In the first option, bare uranium blanket spent nuclear fuel pins with the sodium removed would be melted with aluminum at SRS using technology similar to the technology that DOE selected in the ROD (65 FR 48224, August 7, 2000) for the treatment of aluminum-clad research reactor fuel at SRS. The second and third options would be conducted at ANL-W using metallurgical technology developed for uranium and stainless steel cladding. In the second option, blanket spent nuclear fuel elements would be melted with the cladding and additional stainless steel. In the first two options, dilution of the fissile component of the uranium would not be needed because it is present in amounts far less than in natural uranium. The third option would involve developing a new melt and dilute process capable of handling sodium volatilized from processing the chopped driver spent nuclear fuel elements with the sodium and cladding intact. In this process option, the fuel and stainless steel would be melted under a layer of material such as molten salt to oxidize the molten sodium. The process can be used for the metallic sodium-bonded spent nuclear fuel. The non-metallic uranium nitride, oxide, and carbide sodium-bonded spent nuclear fuel cannot be treated with this process because of their high melting points.

III. Alternatives

The following alternatives were analyzed in the EIS.

Alternative 1—Both driver and blanket fuel would be treated using EMT at ANL-W.

Alternative 2—EMT would be used at ANL-W to treat the driver fuel. The sodium from the blanket fuel would be removed without decladding, and the blanket elements would be packaged in high-integrity cans. Sodium removal and packaging would occur at ANL-W.

Alternative 3—EMT would be used at ANL-W to treat the driver fuel. The fuel pins in the blanket fuel would be separated from the cladding and cleaned to remove metallic sodium at ANL-W. The cleaned fuel pins would be shipped to SRS for treatment using the PUREX process at the F-Canyon facility.

Alternative 4—EMT would be used at ANL-W to treat the driver fuel. The metallic sodium would be removed from the blanket fuel without decladding. Then the elements would be treated using the melt and dilute process. All treatment would occur at ANL-W.

Alternative 5—EMT would be used at ANL-W to treat the driver fuel. The fuel pins in the blanket fuel would be separated from the cladding and cleaned to remove the metallic sodium at ANL-W. Then they would be shipped to SRS and treated using the melt and dilute process.

Alternative 6—Both the driver and blanket fuel would be treated at ANL-W using the melt and dilute process, which would be modified slightly for each fuel type.

No Action Alternative

Under the No Action Alternative, all or part of the sodium-bonded spent nuclear fuel would not be treated (no sodium would be removed), except for stabilization activities that may be necessary to prevent potential degradation of some of the spent nuclear fuel. Two options were analyzed: (1) the sodium-bonded spent nuclear fuel would continue to be stored until 2035 at its current location, subject only to activities dictated by the amended ROD (61 FR 9441, March 1996) for the Programmatic Spent Nuclear Fuel EIS and other existing site-specific NEPA documentation or until another technology, currently dismissed as an unreasonable alternative because it is less mature (e.g., Glass Material Oxidation and Dissolution System (GMODS) or plasma arc), is developed; and (2) the sodium-bonded spent nuclear fuel would be disposed of directly in a geologic repository without treatment. The fuel would be packaged in high-integrity cans without sodium removal. Option 2 would not meet current DOE or Nuclear Regulatory Commission (10 CFR 60.135) repository acceptance criteria.

Preferred Alternative

In the final EIS, DOE identified electrometallurgical treatment as its preferred alternative for the treatment and management of all sodium-bonded spent nuclear fuel, except for the Fermi-1 blanket fuel. The No Action Alternative is preferred for the Fermi-1 blanket spent nuclear fuel. Thus, the preferred alternative is a combination of Alternative 1 and the No Action Alternative.

IV. Alternatives Considered But Dismissed

In identifying the reasonable alternatives for evaluation in the EIS, two separate issues led to the determination of alternatives that were considered and dismissed: (1) the level of maturity of the alternative technologies and (2) the level of effort required to modify an existing facility to implement a specific technology. The construction of new facilities when existing facilities are still operational was not considered a reasonable option because of cost implications. The GMODS process and the direct plasma arc-vitreous ceramic process are not as mature as the electrometallurgical, melt and dilute, and PUREX processes when applied to sodium-bonded spent nuclear fuel. The GMODS and plasma arc processes both require extensive research and development before they can be proven successfully to treat sodium-bonded spent nuclear fuel. The GMODS and plasma arc-vitreous ceramic processes each present specific technological challenges that cannot be answered without demonstration in pilot-scale plants. In comparison, the melt and dilute process is being tested and evaluated and has been selected for treatment of aluminum-clad spent nuclear fuel at SRS. However, use of the melt and dilute process for sodium-bonded driver spent nuclear fuel would require some technology enhancements. In addition, unlike the other technologies that would not require new construction, both of these technologies (i.e., GMODS and plasma arc) would require the installation of large, specialized equipment in new hot cell facilities, the size and complexity of which are not determined sufficiently to allow detailed environmental impact analysis.

V. Summary of Environmental Impacts

This section summarizes the environmental impacts associated with the No Action Alternative and the six alternatives under the proposed action that were evaluated in the EIS. For the No Action Alternative and the six alternatives evaluated, the necessary facilities already exist. Except for internal building modifications and new equipment installation, no construction activities would be required. Therefore, the proposed action would have little or no impact on land resources, visual resources, noise, geology and soils, ecological resources, and cultural and paleontological resources.

For the alternatives evaluated, the analyses showed that there would be no significant impacts on air quality, water resources, socioeconomics, public and occupational health and safety, environmental justice, and transportation. The radiological and nonradiological gas and liquid releases, as well as the associated exposures to workers and the public, would be well within regulatory standards and guidelines.

A fundamental assumption made under the No Action Alternative is that the sodium-bonded spent nuclear fuel will eventually be disposed of in a manner similar to the rest of the spent nuclear fuel owned by DOE and within the time period over which institutional controls could reliably be assumed to be in effect. If the sodium-bonded spent nuclear fuel has not been disposed of before 2035, the temporarily stored fuel would be removed from the State of Idaho by the year 2035. Should such removal be necessary, the potential environmental impacts would be evaluated in a separate NEPA review. The continued storage of sodium-bonded spent nuclear fuel in the State of Idaho or elsewhere, beyond time periods for which institutional controls could reliably be assumed to be effective, could lead to significant impacts to the environment and the health and safety of the public from radioactive releases caused by the gradual degradation of the fuel and its containment.

VI. Environmentally Preferred Alternative

As discussed in the previous section, the environmental impact analysis indicates that none of the action alternatives would result in significant environmental impacts. Further, small differences in potential environmental impacts among the alternatives do not provide a strong basis to discriminate among them. The following discusses some of the small differences.

Transportation: Alternatives involving treatment at ANL-W would avoid the need to transport spent nuclear fuel to SRS, notwithstanding that the analysis shows that the risks associated with such transportation are small.

Waste and Material Streams: The alternatives differ with respect to the quantities and types of waste streams and material that would be produced. The EIS presents a comparison of the volumes of high-level radioactive, low-level radioactive, and transuranic waste for each alternative (e.g., see Table S-4 on Page S-44).

• High-Level Waste. All of the alternatives would result in some form of spent nuclear fuel or high-level waste requiring storage and disposal. PUREX processing would generate liquid high-level waste that would require storage and eventual treatment by vitrification into glass canisters at the SRS. DOE regards the alternative using this technology option as less environmentally preferred than the other action alternatives, primarily because it is the only alternative that would generate liquid high-level waste. On the other hand, the volume of glass high-level waste ultimately produced that would require disposal in a geologic repository would be smaller than the volume of spent nuclear fuel and high level waste under any of the other alternatives. Also, this waste form has been tested and analyzed extensively under potential repository conditions.

Electrometallurgical treatment would produce two new high-level waste forms (i.e., metallic and ceramic), and the melt and dilute process also would produce a new metallic form (i.e., a melt and dilute product). DOE expects that these waste forms and high-integrity cans that do not contain metallic sodium would be suitable for disposal in a geologic repository.

• Low-Level and Transuranic Waste. With the exception of Alternative 2, all of the action alternatives would generate greater volumes of low-level and transuranic waste than the No Action Alternative. Existing waste management infrastructure is adequate to safely manage these wastes under all of the alternatives, and the EIS shows that the associated environmental impacts would be small.

• Other Material Streams. Two of the treatment technology options would generate other material streams requiring storage and disposition. Electrometallurgical treatment would produce low-enriched and depleted uranium ingots, which would be stored safely pending decisions on their ultimate disposition. PUREX processing would generate uranium oxide and plutonium metal. The uranium oxide would be stored at SRS as depleted uranium, and the plutonium would be subject to the Record of Decision for the Surplus Plutonium Disposition Final Environmental Impact Statement.

Long-Term Uncertainties: The No Action Alternative would result in the least environmental impacts in the short-term. However, under the No Action Alternative metallic sodium would not be removed or converted to a non-reactive form and would pose long-term risks. Further, if treatment were required in the future to remove or deactivate the sodium, the associated environmental impacts would be incurred then. In contrast, all of the action alternatives would either remove or convert the metallic sodium into a non-reactive form, which would reduce the risks associated with long-term storage and uncertainties regarding disposal.

VII . Other Considerations

In addition to environmental issues, DOE considered other issues in determining the treatment and disposition path of sodium-bonded spent nuclear fuel. Among these are cost, nuclear proliferation concerns, and the National Research Council's independent review of electrometallurgical techniques, including the research and demonstration project.

DOE's Cost Study of Alternatives Presented in the Draft Environmental Impact Statement for the Treatment and Management of Sodium-Bonded Spent Nuclear Fuel showed that the lowest cost alternative was the direct disposal option under the No Action alternative. However, untreated sodium-bonded spent nuclear fuel does not meet current DOE or Nuclear Regulatory Commission repository acceptance criteria requirements. The cost study also concluded that the cost of alternatives 1, 2, and 3 are similar and difficult to distinguish from each other, as are the costs of alternatives 4, 5, and 6. This is due to an incomplete understanding of the technical requirements for the treatment technology, uncertainty in the repository waste acceptance criteria, and unquantifiable programmatic risks associated with some of the alternatives.

After reviewing the various alternatives, DOE's Office of Arms Control and Nonproliferation concluded that “All but one alternative—the one involving plutonium-uranium extraction reprocessing at the SRS—are fully consistent with U.S. policy with respect to reprocessing and nonproliferation.” (DOE/Office of Arms Control and Nonproliferation, Nonproliferation Impacts Assessment for the Treatment and Management of Sodium-Bonded Spent Nuclear Fuel, July 1999)

The National Research Council's final report on Electrometallurgical Techniques for DOE Spent Fuel Treatment (April 2000) concluded that “The EBR-II demonstration project has shown that the electrometallurgical technique can be used to treat sodium-bonded spent nuclear fuel.” The report further stated that “the committee has found no significant technical barriers in the use of electrometallurgical technology to treat EBR-II spent fuel, and EMT therefore represents a potentially viable technology for DOE spent nuclear fuel treatment.”

VIII. Decision

DOE has decided to implement the preferred alternative as stated in the final EIS. That is, DOE will electrometallurgically treat the EBR-II spent nuclear fuel (about 25 metric tons of heavy metal) and miscellaneous small lots of sodium-bonded spent nuclear fuel. The fuel will be treated at ANL-W. In addition, Fermi-1 sodium-bonded spent nuclear fuel (about 35 metric tons of heavy metal) will be stored while alternative treatments are evaluated further. Should no alternative prove more cost-effective for this spent nuclear fuel, electrometallurgical treatment of the Fermi-1 spent nuclear fuel remains a key option.

DOE will validate the cost of using alternative treatment techniques (e.g., sodium removal and placement in high-integrity cans) for the Fermi-1 blanket spent nuclear fuel. These techniques may be economically favorable for the Fermi-1 blanket spent nuclear fuel because of characteristics that distinguish it from the EBR-II spent nuclear fuel. The most significant distinguishing characteristic is that the Fermi-1 blanket spent nuclear fuel does not require the extensive safeguards and security measures that are required for the EBR-II blanket fuel. The difference in security requirements for these two types of fuel is a result of the difference in plutonium content; the EBR-II blanket fuel has 30 times more plutonium at a greater concentration than the Fermi-1 blanket fuel. DOE will proceed with the electrometallurgical treatment of the EBR-II spent nuclear fuel and monitor the results and costs while continuing the evaluation of sodium removal techniques for the Fermi-1 blanket spent nuclear fuel. While EBR-II spent nuclear fuel is undergoing electrometallurgical treatment and the Fermi-1 blanket spent nuclear fuel remains in storage, DOE has approximately four years in which to evaluate the operating experience of electrometallurgical treatment technology and further evaluate other alternatives for the Fermi-1 blanket spent nuclear fuel. After these data are evaluated, DOE will decide whether to treat the Fermi-1 blanket spent nuclear fuel using electrometallurgical treatment or to use another treatment method and/or disposal technique.

For several years, DOE has been actively developing electrometallurgical treatment technology specifically for the management of sodium-bonded spent nuclear fuel. Having completed a successful demonstration of electrometallurgical treatment, DOE believes that this technology has the highest probability of meeting the objective of reducing the uncertainties associated with qualifying the sodium-bonded spent nuclear fuel for disposal in a geologic repository. Electrometallurgical technology will convert the reactive fuel into ceramic and metallic waste forms, both of which are more stable than untreated sodium-bonded spent nuclear fuel. In addition, uranium would be separated from the spent nuclear fuel, blended with depleted uranium if needed to reduce the enrichment levels, and cast into ingots to be stored until a disposition decision is made through a separate NEPA review. Most of the plutonium will be disposed of in the ceramic waste form, with the remaining small fraction disposed of in the metallic waste form. Currently, the only waste form that has been tested and analyzed extensively under geologic repository conditions and may be accepted for repository disposal is borosilicate glass. Tests have shown that the ceramic and metallic waste forms from electrometallurgical treatment may perform as well as the standard borosilicate glass waste form. The ceramic and metallic waste forms would require less storage volume than untreated spent nuclear fuel.

IX. Mitigation

The strictly controlled conduct of operations associated with DOE's spent nuclear fuel management activities are integral to the selected alternative. DOE has directives and regulations for safe conduct of spent nuclear fuel treatment and management operations. DOE has adopted stringent controls for minimizing occupational and public radiation exposure. The policy is to reduce radiation exposures to as low as reasonably achievable. Singly and collectively, these measures avoid, reduce, or eliminate any potentially adverse environmental impacts from spent nuclear fuel treatment and management. DOE has not identified a need for additional mitigation measures.

This notice announces the third in a series of meetings of the Secretary of Energy Advisory Board's Panel on Emerging Technological Alternatives to Incineration. The Federal Advisory Committee Act (Public Law 92-463, 86 Stat. 770), requires that agencies publish these notices in the Federal Register to allow for public participation.

U.S. Department of Energy, Program Review Center, Room 8E-089, 1000 Independence Avenue, SW., Washington, DC 20585. Note: Members of the public are requested to contact the Office of the Secretary of Energy Advisory Board at (202) 586-7092 in advance of the meeting (if possible), to expedite their entry to the Forrestal Building on the day of the meeting.

The purpose of the Secretary of Energy Advisory Board's Panel on Emerging Technological Alternatives to Incineration is to provide independent external advice and recommendations to the Secretary of Energy Advisory Board on emerging technological alternatives to incineration for the treatment of mixed waste which the Department of Energy should pursue. The Panel will focus on the evaluation of emerging non-incineration technologies for the treatment of low-level, alpha low-level and transuranic wastes containing polychlorinated biphenyls (PCBs) and other hazardous constituents. Waste categories to be addressed include inorganic homogeneous solids, organic homogeneous solids, and soils. The Panel will also evaluate whether the emerging non-incineration technologies could be implemented in a manner that would allow the Department of Energy to comply with all legal requirements, including those contained in the Settlement Agreement and Consent Order signed by the State of Idaho, Department of Energy, and the U.S. Navy in October 1995.

Tentative Agenda

The agenda for the September 27 meeting has not been finalized. However, the meeting will include panel discussion and presentations on Waste Characterization and R&D Plans for Tru Mixed Waste. Members of the Public wishing to comment on issues before the Panel on Emerging Technological Alternatives to Incineration will have an opportunity to address the Panel during the scheduled public comment period. The final agenda will be available at the meeting.

In keeping with procedures, members of the public are welcome to observe the business of the Panel on Emerging Technological Alternatives to Incineration and submit written comments or comment during the scheduled public comment period. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. The Panel will make every effort to hear the views of all interested parties. The Chairman of the Panel is empowered to conduct the meeting in a fashion that will, in the Chairman's judgment, facilitate the orderly conduct of business. You may submit written comments to Mary Louise Wagner, Executive Director, Secretary of Energy Advisory Board, AB-1, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, D.C. 20585. This notice is being published less than 15 days before the date of the meeting due to the late resolution of programmatic issues.

Minutes

A copy of the minutes and a transcript of the meeting will be made available for public review and copying approximately 30 days following the meeting at the Freedom of Information Public Reading Room, 1E-190 Forrestal Building, 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday except Federal holidays. Further information on the Secretary of Energy Advisory Board and its subcommittees may be found at the Board's web site, located at http://www.hr.doe.gov/seab.

Take notice that on September 11, 2000, Alternate Power Source, Inc. (APS), tendered for filing a Complaint under Section 206 and 306 of the Federal Power Act in which APS petitions the Commission for an order directing ISO New England, Inc. (ISO-NE) to suspend the April, 2000 ICAP auction “clearing price”; cease and desist from requiring APS to pay into escrow $700,000 for the month of April, 2000; cease and desist from “settling” the ICAP prices for the months of May, June and July, 2000, and from requiring any payments into escrow until a thorough investigation of all conduct and actions is completed; and if, after an investigation, there is a finding of anomalous conduct in the so-called ICAP auction “market” for the months April through July, 2000, direct ISO-NE to mitigate ICAP prices for those months.

Any person desiring to be heard or to protest this filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions or protests must be filed on or before September 21, 2000. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection in the Public Reference Room. This filing may also be viewed on the Internet at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222) for assistance. Answers to the complaint shall also be due on or before September 21, 2000.

On September 7, 2000, The Canadian-Montana Pipeline Corporation (CMPL) and 3698157 Canada Ltd. (Canada Ltd.) filed an application pursuant to Section 3 of the Natural Gas Act (NGA) and Section 153 of the Commission's Regulations and Executive Order No. 10485, as amended by Executive Order No. 12038, seeking authorization to transfer CMPL's existing NGA Section 3 authorization and Presidential Permit to Canada Ltd., all as more fully set forth in the application which is on file with the Commission and which is open to the public for inspection. This filing may be viewed at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).

Any questions regarding the applications should be directed to William A. Pascoe, Vice President of Gas Operations, 40 East Broadway, Butte, Montana 59701, (406) 497-4212.

Specifically, CMPL and Canada Ltd. request the Commission to issue an order: (1) transferring NGA Section 3 authorization to site, construct and operate facilities for the importation of natural gas from the Province of Saskatchewan, Canada, into Montana; and (2) authorizing the assignment of CMPL's June 18, 1999 Presidential Permit to construct, operate and maintain facilities at the Saskatchewan, Canada/Montana import point.

The import facilities consist of (1) a gas meter station in LSD 5-4-1-14 W3M adjacent to Highway 4 approximately 0.5 mile north of the Village of Monchy, Saskatchewan; and (2) a 219.1 mm O.D. pipeline located directly south of this meter station across the Canada-United States border at Section 6 T37N R30E, extending a distance of approximately 2438 feet. The pipeline crosses the International Boundary and interconnects with a gathering line owned by North American Resources Company in Montana at the property line of the Montana landowner.

CMPL and Canada Ltd. states that the requested transfer and assignment would facilitate the sale of facilities pursuant to a June 28, 2000 Agreement of Purchase and Sale and the transfer and assignment would not affect the underlying use of the facilities.

Any person desiring to be heard or to make any protest with reference to said application should on or before October 4, 2000, file with the Federal Energy Regulatory Commission, 888 First Street, N.E., Washington, DC 20426, a motion to intervene or a protest in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 and 385.211). All protests filed with the Commission will be considered by it in determining the appropriate action to be taken, but will not serve to make the protestants parties to the proceeding. Any person wishing to become a party to a proceeding or to participate as a party in any hearing therein must file a motion to intervene in accordance with the Commission's Rules.

A person obtaining intervenor status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by every one of the intervenors. An intervenor can file for rehearing of any Commission order and can petition for court review of any such order. However, an intervenor must submit copies of comments or any other filings it makes with the Commission to every other intervenor in the proceeding, as well as an original and 14 copies with the Commission.

A person does not have to intervene, however, in order to have environmental comments considered. A person, instead, may submit two copies of comments to the Secretary of the Commission. Commenters will be placed on the Commission's environmental mailing list, will receive copies of environmental documents and will be able to participate in meetings associated with the Commission's environmental review process. Commenters will not be required to serve copies of filed documents on all other parties. However, commenters will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek rehearing or appeal the Commission's final order to a federal court.

The Commission will consider all comments and concerns equally, whether filed by commenters or those requesting intervenor status.

Take further notice that, pursuant to the authority contained in and subject to jurisdiction conferred upon the Federal Energy Regulatory Commission by Sections 7 and 15 of the Natural Gas Act and the Commission's Rules of Practice and Procedure, a hearing will be held without further notice before the Commission or its designee on this application if no motion to intervene is filed within the time required herein, if the Commission on its own review of the matter finds that a grant of the certificate is required by the public convenience and necessity. If a motion for leave to intervene is timely filed, or if the Commission on its motion believes that a formal hearing is required, further notice of such hearing will be duly given.

Under the procedure herein provided for, unless otherwise advised, it will be unnecessary for CMPL and Canada Ltd. to appear or be represented at the hearing.

The route review originally scheduled for September 19 and 20, 2000, has been rescheduled for September 20 and 21, 2000. The staff of the Office of Energy Projects (OEP) will conduct the route review of the existing Index 1 Pipeline and related laterals proposed for abandonment by Koch Gateway Pipeline Company (Koch). These facilities were the subject of an Environmental Assessment prepared by the OEP staff and issued for public review and comment on January 27, 2000. The routes, located in the Dallas-Fort Worth area of Texas, will be inspected by automobile. Representatives of Koch will accompany the OEP staff.

Anyone interested in attending the route review or obtaining further information may contact Mr. Paul McKee of the Commission's External Affairs Office at (202) 208-1088. Attendees must provide their own transportation.

On September 7, 2000, The Montana Power Company (MPC) and 3698157 Canada Ltd. (Canada Ltd.) filed an application pursuant to Section 3 of the Natural Gas Act (NGA) and Section 153 of the Commission's Regulations and Executive Order No. 10485, as amended by Executive Order No. 12038, seeking authorization to transfer MPC's existing NGA Section 3 authorization and Presidential Permit to Canada Ltd., all as more fully set forth in the application which is on file with the commission and which is open to the public for inspection. This filing may be viewed at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).

Any questions regarding the applications should be directed to William A. Pascoe, Vice President of Gas Operations, 40 East Broadway, Butte, Montana, 59701, (406) 497-4212.

Specifically, MPC and Canada Ltd. request the Commission to issue an order: (1) transferring NGA Section 3 authorization to site, construct and operate facilities at Reagan, Alberta and Del Bonita, Montana for the importation of natural gas into the United States; and (2) authorizing the assignment of MPC's November 20, 1981 Presidential Permit to construct, operate and maintain facilities at the Reagan/Del Bonita import point.

The import facilities consist of a section of 41/2-inch pipe extending from the interconnection with the Canadian-Montana Pipe Line Company system on the Northern side of the international boundary between the United States and Canada and includes approximately 1 mile of pipe extending in a southerly direction to a point of interconnection with The Montana Power Gas Company gathering facilities in Glacier County, Montana.

MPC and Canada Ltd. states that the requested transfer and assignment would facilitate the sale of facilities pursuant to a June 28, 2000 Agreement of Purchase and Sale and the transfer and assignment would not affect the underlying use of the facilities.

Any person desiring to be heard or to make any protest with reference to said application should on or before October 4, 2000, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene or a protest in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 and 385.211). All protests filed with the Commission will be considered by it in determining the appropriate action to be taken, but will not serve to make the protestants parties to the proceeding. Any person wishing to become a party to a proceeding or to participate as a party in any hearing therein must file a motion to intervene in accordance with the Commission's Rules.

A person obtaining intervenor status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by every one of the intervenors. An intervenor can file for rehearing of any Commission order and can petition for court review of any such order. However, an intervenor must submit copies of comments or any other filings it makes with the Commission to every other intervenor in the proceeding, as well as an original and 14 copies with the Commission.

A person does not have to intervene, however, in order to have environmental comments considered. A person, instead, may submit two copies of comments to the Secretary of the Commission. Commenters will be placed on the Commission's environmental mailing list, will receive copies of environmental documents and will be able to participate in meetings associated with the Commission's environmental review process. Commenters will not be required to serve copies of filed documents on all other parties. However, commenters will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek rehearing or appeal the Commission's final order to a federal court.

The Commission will consider all comments and concerns equally, whether filed by commenters or those requesting intervenor status.

Take further notice that, pursuant to the authority contained in and subject to jurisdiction conferred upon the Federal Energy Regulatory Commission by Sections 7 and 15 of the Natural Gas Act and the Commission's Rules of Practice and Procedure, a hearing will be held without further notice before the Commission or its designee on this application if no motion to intervene is filed within the time required herein, if the Commission on its own review of the matter finds that a grant of the certificate is required by the public convenience and necessity. If a motion for leave to intervene is timely filed, or if the Commission on its motion believes that a formal hearing is required, further notice of such hearing will be duly given.

Under the procedure herein provided for, unless otherwise advised, it will be unnecessary for MPC and Canada Ltd. to appear or be represented at the hearing.

Take notice that on September 8, 2000, the New York Independent System Operator, Inc. (NYISO), filed a motion requesting leave to submit revised tariff sheets out of time and a corrected combined compliance filing and report in the above-captioned proceedings. The original combined compliance filing and report was filed on September 1, 2000. The corrected combined filing proposes that the requested tariff changes become effective on November 1, 2000, with the single exception of a provision governing the payment of lost opportunity costs to suppliers of 10-Minute reserves, which the filing proposes be made retroactively effective on May 31, 2000.

A copy of this filing was served upon all parties in the above-captioned proceeding.

Any person desiring to be heard or to protest such filing should file a motion to intervene or protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). All such motions and protests should be filed on or before September 27, 2000. Protests will be considered by the Commission to determine the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. Copies of this filing are on file with the Commission and are available for public inspection. This filing may also be viewed on the Internet at http://www.ferc.fed.us/online/rims.htm (call 202-208-2222 for assistance).

This notice also extends the time for filing motions and protests in response to the September 1, 2000 filing by NYISO and noticed on September 7, 2000 in Docket No. ER00-3591-000, from September 22, 2000 to September 27, 2000.

On January 4, 1999, Northbrook Carolina Hydro, LLC, licensee for the Idols Project No. 2585, filed an application for surrender of license pursuant to the Federal Power Act (FPA) and the Commission's regulations thereunder. Project No. 2585 is located on the Yadkin River in Forsyth and Davie Counties, North Carolina.

The license for Project No. 2585 was issued for a period ending July 31, 2000. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year to year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in Section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of Section 15 of the FPA, then, based on Section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.

If the project is subject to Section 15 of the FPA, notice is hereby given that an annual license for Project No. 2585 is issued for a period effective August 1, 2000, through July 31, 2001, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before July 31, 2001, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under Section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.

If the project is not subject to Section 15 of the FPA, notice is hereby given that Northbrook Carolina Hydro, LLC is authorized to continue operation of the Idols Project No. 2585 until such time as the Commission acts on its application for subsequent license.

In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Federal Energy Regulatory Commission's (Commission's) regulations, 18 CFR part 380 (Order No. 486, 52 F.R. 47897), the Office of Energy Projects has reviewed the application for an original license for the proposed Stockport Mill Country Inn Water Power Project, located on the Muskingum River, near the town of Stockport, Morgan County, Ohio, and has prepared an Environmental Assessment (EA) for the project. In the EA, the Commission's staff has analyzed the potential environmental impacts of the project and has concluded that licensing the project, with appropriate environmental protection measures, would not constitute a major Federal action significantly affecting the quality of the human environment.

Copies of the EA are available for review in the Public Reference Branch, Room 2-A, of the Commission's offices at 888 First Street, NE., Washington, DC 20426. The EA may also be viewed on the web at http://www.ferc.fed.us/online/rims.htm. Please call (202) 208-2222 for assistance.

Any comments should be filed within 30 days from the date of this notice and should be addressed to David P. Boergers, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Room 1-A, Washington, DC 20426. Please affix “Stockport Mill Country Inn Project No. 11685” to all comments. For further information, contact Tom Dean at (202) 219-2778.

The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Columbia Liberty Project involving construction and operation of facilities by Texas Eastern Transmission Corporation (Texas Eastern) in Chester and Delaware Counties, Pennsylvania.1 Texas Eastern proposes to expand its existing Philadelphia Lateral System to supply 84,000 dekatherms per day of natural gas to the Columbia Liberty Plant, a 567.7 megawatt gas-fired electric power plant presently being constructed in the Borough of Eddysburg in Delaware County, Pennsylvania.

1 Texas Eastern's application was filed with the Commission on July 13, 2000, under Section 7 of the Natural Gas Act and Part 157 of the Commission's regulations.

If you are a landowner on Texas Eastern's existing or proposed route and receive this notice, you may be contacted by a pipeline company representative about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The pipeline company would seek to negotiate a mutually acceptable agreement. However, if the project is approved by the Commission, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings in accordance with state law.

A fact sheet prepared by FERC entitled “An Interstate Gas Facility On My Land? What Do I Need To Know?” was attached to the project notice Texas Eastern provided to landowners. This fact sheet addresses a number of typically asked questions, including the use of eminent domain. It is available for viewing on the FERC Internet website (www.ferc.fed.us).

This Notice of Intent (NOI) is being sent to landowners along Texas Eastern's existing and proposed routes; Federal, state, and local government agencies; elected officials; regional environmental, and public interest groups Indian tribes that might attach religious and cultural significance to historic properties in the area of potential effects; local libraries and newspapers; and the Commission's service list and parties to the proceeding. Government representatives are encouraged to notify their constituents of this proposed action and encourage them to comment on their areas of concern. Additionally, with this NOI we are asking Federal, state, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues to cooperate with us in the preparation of the EA. These agencies may choose to participate once they have evaluated Texas Eastern's proposal relative to their agencies' responsibilities. Agencies who would like to request cooperating status should follow the instructions for filing comments described below.

Summary of the Proposed Project

Texas Eastern proposed to install one 4,000 horsepower electric compressor at its existing Eagle Compressor Station; to replace various segments of its existing 20-inch-diameter Line No. 1-A; and to construction about 0.6 mile of 12-inch-diameter pipeline and associated metering facilities to connect with the Columbia Liberty Plant. To supply the required volumes to the power plant Texas Eastern proposes to increase the operating pressure of Line No. 1-A from 400 pounds per square inch gauge (psig) to 656 psig.

The general location of Texas Eastern's proposed facilities is shown on the map attached as appendix 1.2

2 The appendices referenced in this notice are not being printed in the Federal Register. Copies are available on the Commission's website at the “RIMS” link or from the Commission's Public Reference and Files Maintenance Branch, 888 First Street, NE, Room 2A, Washington, DC 20426, or call (202) 208-1371. For instructions on connecting to RIMS refer to the last page of this notice. Copies of the appendices were sent to all those receiving this notice in the mail.

Land Requirements for Construction

Construction of the Texas Eastern's proposed facilities would affect about 39.3 acres of land. Texas Eastern proposes to use 10.4 acres for construction of the new Liberty Lateral and 28.9 acres for replacing segments on Line 1-A. Following construction, about 3.5 acres would be retained as new permanent right-of-way for the new pipeline facilities. The remaining 35.8 acres of temporary work space would be restored and allowed to revert to its former use.

The EA Process

The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us 3 to discover and address concerns the public may have about proposals. We call this “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this NOI, the Commission requests public comments on the scope of the issues it will address in the EA. All comments received are considered during the preparation of the EA.

3 “Us,” “we,” and “our” refer to the environment staff of the FERC's Office of Pipeline Regulation.

Our independent analysis of the issues will be in the EA. Depending on the comments received during the scoping process, the EA may be published and mailed to Federal, state, and local agencies, elected officials, affected landowners, regional public interest groups, Indian tribes, local newspapers and libraries, and the Commission's official service list for this proceeding. A comment period will be alloted for review if the EA is published. We will consider all comments on the EA before we make our recommendations to the Commission.

Currently Identified Environmental Issues

The EA will discuss impacts that could occur as a result of construction and operation of the proposed project. We have already identified a number of issues that we think deserve attention based on a preliminary review of the proposed facilities and the environmental information provided by Texas Eastern. This preliminary list of issues may be changed based on your comments and our analysis.

• Noise—Affects from the addition of a 4,000 horsepower compressor unit.

Public Participation and Site Visit

You can make a difference by providing us with your specific comments or concerns about the project. By becoming a commentor, your concerns will be addressed in the EA and considered by the Commission. You should focus on the potential environmental effects of the proposal, alternatives to the proposal (including alternative locations or routes), and measures to avoid or lessen environmental impact. The more specific your comments, the more useful they will be. Please carefully follow these instructions to ensure that your comments are received in time and properly recorded:

• Label one copy of the comments for the attention of the Gas Group 1, PJ-11.1;

• Reference Docket No. CP00-404-000; and

• Mail your comments so that they will be received in Washington, DC on or before October 13, 2000.

[If you do not want to send comments at this time but still want to remain on our mailing list, please return the Information Request (appendix 3). If you do not return the Information Request, you may be removed from the environmental mailing list.]

On September 29, 2000, the Office of Energy Projects staff will conduct a precertification site visit of the project route and possible reroutes. All parties may attend. Those planning to attend must provide their own transportation. We will be meeting in the parking lot at the Ramada Inn in Essington at 8:30 am.

For further information on attending the site visit, please contact the Commission's Office of External Affairs at (202) 208-0004.

Becoming an Intervenor

In addition to involvement in the EA scoping process, you may want to become an official party to the proceeding known as an “intervenor.” Intervenors play a more formal role in the process. Among other things, intervenors have the right to receive copies of case-related Commission documents and filings by other intervenors. Likewise, each intervenor must provide 14 copies of its filings to the Secretary of the Commission and must send a copy of its filings to all other parties on the Commission's service list for this proceeding. If you want to become an intervenor you must file a motion to intervene according to Rule 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.214) (see appendix 2). Only intervenors have the right to seek rehearing of the Commission's decision.

Affected landowners and parties with environmental concerns may be granted intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which would not be adequately represented by any other parties. You do not need intervenor status to have your environmental comments considered.

Additional information about the proposed project is available from the Commission's Office of External Affairs at (202) 208-0004 or on the FERC website (www.ferc.fed.us) using the “RIMS” link to information in this docket number. Click on the “RIMS” link, select “Docket #” from the RIMS Menu, and follow the instructions. For assistance with access to RIMS, the RIMS helpline can be reached at (202) 208-2222.

Similarly, the “CIPS” link on the FERC Internet website provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings. From the FERC Internet website, click on the “CIPS” link, select “Docket #” from the CIPS menu, and follow the instructions. For assistance with access to CIPS, the CIPS helpline can be reached at (202) 208-2474.

Take notice that the following application has been filed with the Commission and is available for public inspection.

(a) Type of Application: Amendment of license for the non-project use of project lands and waters: the construction and operation of a water intake and a portion of planned raw water pumping facilities on 0.2 acres of project lands, and the withdrawal of up to 28 million gallons per day (GPD) from Blewett Falls Lake.

i. FERC Contact: Any questions on this notice should be addressed to Jim Haimes at (202) 219-2780, or e-mail address: james.haimes@ferc.fed.us.

j. Deadline for filing comments and or motions: 30 days from the issuance date of this notice.

All documents (original and eight copies) should be filed with: David P. Boergers, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE, Washington, DC 20426. Please include the project number (P-2206-014) on any comments or motions filed.

k. Description of Project: Carolina Power and Light Company (applicant) requests Commission authorization to grant an easement to Richmond County, North Carolina, for (1) the construction and operation of a water intake and a portion of planned raw water pumping facilities on 0.212 acres of project lands; and (2) the withdrawal of up to 28 million gallons per day (MGD) from Blewett Falls Lake for municipal water supply.

l. Locations of the application: Copies of the application are available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street, NE, Room 2A, Washington, DC 20426, or by calling (202) 208-1371. The application also may be viewed on the Web at www.ferc.fed.us/online/rims.htm. Call (202) 208-2222 for assistance. Copies of the application also are available for inspection and reproduction at the addresses in item h, above.

m. Individuals desiring to be included on the Commission's mailing list for the proposed amendment of license should so indicate by writing to the Secretary of the Commission.

n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for this notice.

o. Filing and Service of Responsive Documents—Any filing must bear in all capital letters the title “COMMENTS”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTESTS”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the subject application, No. 2206-014. A copy of any motion to intervene must also be served upon Applicant's representative specified in item h, above.

p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If any agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representative.

The Chesapeake Bay Program has developed a Draft Guidance Document for Nutrient Trading in the Chesapeake Bay. The document presents fundamental principles and guidelines for nutrient trading in the Chesapeake Bay watershed. This document is available to the public for review from September 8, 2000 through October 27, 2000.

The document is available starting September 8, 2000 at the following web-site: http://www.chesapeakbay.net/trading.html. You may request a paper copy by calling Julie Trask at 410-267-5753 or by e-mail at trask.julie@epa.gov. All comments must be sent to the appropriate state contact listed below by Oct. 27, 2000:

In accordance with the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9601 et seq., and the authority of the Attorney General of the United States to compromise and settle claims of the United States as delegated, notice is hereby given of a proposed prospective purchaser agreement concerning a portion of the Master Metals, Inc., Superfund site at 2850 W. Third Street, Cleveland, Cuyahoga County, Ohio, 44113, with the Midwest Railway Preservation Society, Inc. (MRPS). The agreement covers approximately .4 acres of the approximately 4.3 acre site. The agreement requires MRPS to pay $2,000 to the Hazardous Substance Superfund; to grant future access rights; and to record appropriate deed notices. The agreement includes a covenant not to sue MRPS under sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a) and contribution protection for MRPS under section 113(f)(2), 42 U.S.C. 9613(f)(2). For thirty (30) days following the date of publication of this notice, the United States will receive written comments relating to the agreement. The United States will consider all comments received and may modify or withdraw its consent to the agreement if comments received disclose facts or considerations which indicate that the agreement is inappropriate, improper, or inadequate. The United States' response to any comments received will be available for public inspection at U.S. EPA, Region 5, 77 W. Jackson Boulevard, Chicago, IL 60604. Please contact Gwen Massenburg, Remedial Project Manager, at (312) 886-0983 to make arrangements to inspect the comments.

DATES:

Comments must be submitted on or before September 19, 2000.

ADDRESSES:

The proposed settlement is available for public inspection at U.S. EPA, Region 5, 77 W. Jackson Boulevard, Chicago, IL 60604. A copy of the proposed agreement may be obtained from Kris Vezner, Assistant Regional Counsel, at U.S. EPA, Region 5, 77 W. Jackson Boulevard (C-14J), Chicago, IL 60604, phone (312) 886-6827. Comments should reference the “Master Metals, Inc., Superfund Site— Cleveland—prospective purchaser agreement,” and should be addressed to Mr. Vezner.

Dated: September 6, 2000. William E. Muno,Director, Superfund Division, U.S. EPA Region 5.[FR Doc. 00-24045 Filed 9-18-00; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [FRL-6871-9] Application From the States of Utah and Arizona for the Prohibition of the Discharge of Vessel Sewage Into Lake Powell; Notice of Determination

This notice is to announce that discharging sewage, whether treated or not, from vessels into Lake Powell is now prohibited.

Lake Powell is a reservoir on the Colorado River and is impounded by the Glen Canyon Dam at Page, Arizona. Approximately 95 percent of Lake Powell is located in Utah and 5 percent is in Arizona. The States of Utah and Arizona have jointly petitioned the Regional Administrators from Regions 8 and 9 of the United States Environmental Protection Agency (EPA) to prohibit the discharge of sewage from all vessels into Lake Powell. Under section 312(f)(3) of the Clean Water Act, 33 U.S.C. 1322(f)(3), any state may make a prohibition of this type. However, no such prohibition is to apply until the EPA has determined that adequate facilities are reasonably available for the safe and sanitary removal and treatment of sewage from all vessels on the water to be covered by the prohibition.

On May 22, 2000, the EPA published a notice in the Federal Register describing the States' application. (See 65 FR 32093.) In the notice, the EPA announced that it proposed to make an affirmative determination that adequate facilities exist. The EPA also asked for comments on the States' application. The 45-day public comment period ended on July 6, 2000, and the EPA received no comments.

Today the EPA is finalizing its determination that adequate facilities are reasonably available for the safe and sanitary removal and treatment of sewage from all vessels on Lake Powell. With this determination, the States' prohibition against discharging any sewage, whether treated or not, from any vessel into Lake Powell is now in effect.

According to the States' application, jurisdictional and enforcement authority for this prohibition will reside with the respective States and the National Park Service. The Utah Department of Environmental Quality, the Utah Department of Natural Resources, the Arizona Department of Environmental Quality, the Arizona Department of Fish and Game, the United States Coast Guard and the National Park Service, and Glen Canyon National Recreation Area, will all be the enforcing agents supporting the prohibition. The Navajo Nation bounds on the southeast portion of Lake Powell, but the jurisdiction of the Navajo Nation is not affected by the application of Utah and Arizona.

The States' application certifies that there are six authorized vessel entry/take-out points on the Lake: Wahweap, Stateline, Hite, Bullfrog, Hall's Crossing, and Antelope Point. The first five locations have major pumpout facilities. Due to the geomorphology of the Lake, it is nearly impossible to remove or launch a vessel from any other point on the Lake. A major water accessible vessel pumpout facility is also located at Dangling Rope. Each major facility has multiple pumps. In addition, eight supplemental mechanically operated floating pump out facilities are located at various areas on the Lake. These pumps are: Warm Creek Bay, located in Warm Creek Bay; Dominiquez Butte, near Lake Powell Channel Mile Marker 22; Rock Creek, near Lake Powell Channel Mile Marker 35; Oak Bay, located near Lake Powell Channel Mile Marker 51; Escalante, located near Lake Powell Channel Mile Marker 68A; Rincon, near Lake Powell Channel Mile Marker 77A; Hall's Creek Bay, located in Hall's Creek Bay on the Eastside; and Forgotten Canyon, near Lake Powell Channel Mile Marker 106. There is a total of sixty-nine pumpouts on the Lake. All the facilities identified above are operational 24 hours per day. None of the facilities identified will exclude any vessel because of insufficient water depth adjacent to the facility. There are no fees to pump out at any facility. Treatment of all wastes from the pumpout facilities is to be in conformance with Federal law. This prohibition action is, therefore, intended to prevent discharge of human wastes to the waters of the Lake to protect public health and the water quality of this important national resource.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a current valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

DATES:

Written comments should be submitted on or before November 20, 2000. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

For additional information or copies of the information collection(s) contact Les Smith at 202-418-0217 or via the Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060-0624.

Title: Amendment of the Commission's Rules to Establish New Personal Communications Services—Section 24.103(f).

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or households; business or other for-profit entities; not-for-profit institutions; and State, Local or Tribal Government.

Number of Respondents: 1,782.

Estimated Time Per Response: 15.1 hrs. (avg.).

Frequency of Response: 1, 5, or 10 yrs.

Total Annual Burden: 26,843 hrs.

Total Annual Cost: $0.

Needs and Uses: 47 CFR 24.103(f) requires narrowband PCS licensees to notify the Commission at specific benchmarks that systems are in compliance with construction requirements. Requirements were adopted to ensure that licensees quickly construct their systems and that the systems serve significant areas.

The Federal Communications Commission (FCC) has received Office of Management and Budget (OMB) approval for the following public information collections pursuant to the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid control number. For further information contact Shoko B. Hair, Federal Communications Commission, (202) 418-1379.

Federal Communications Commission

OMB Control No.: 3060-0921.

Expiration Date: 08/31/2003.

Title: Petitions for LATA Boundary Modification for the Deployment of Advanced Services.

Description: Bell Operating Companies (BOCs) that petition for LATA boundary modifications to encourage the deployment of advanced services on a reasonable and timely basis are requested to include information in accordance with specified criteria outlined in CC Docket No. 98-147, released 2/11/2000 (FCC No. 00-26). In order to review requests for LATA modifications promptly and efficiently, it is necessary that BOCs provide the information specified. The criteria set forth in the order will serve to ease the petition process on BOCs by providing guidelines that will serve to narrow the scope of their petitions to the issues and facts that the Commission is primarily concerned with. In addition, the request will also expedite the petition review process by ensuring that petitioners will provide all of the information the Commission needs to properly review the requests. Obligation to respond: Required to obtain or retain benefits.

Description: Tier 1 local exchange carriers (except NECA members) are required to make tariff filings to provide certain signalling information to interested parties so that those parties can provide tandem switching services. Tandem switching providers are required to provide certain billing information to those Tier 1 local exchange carriers. The tariffs and cost support information accompanying them are used by the FCC staff to ensure that the tariff rates are paid for, signalling information are just, reasonable, and nondiscriminatory, as sections 201 and 202 of the Communications Act of 1934, as amended, require. Without this information, the FCC would be unable to determine whether the rates for these services are just, reasonable, nondiscriminatory, and otherwise in accordance with the law. Tariffs are used by parties using signalling information to ascertain the charges and other terms and conditions applicable to these offerings. Signalling information is necessary so that parties can provide tandem switching services. Obligation to respond: Mandatory.

Description: 47 CFR Part 52, Subpart C implements the statutory requirement that local exchange carriers (LECs) provide number portability as set forth in Section 251 of the Telecommunications Act of 1996 (1996 Act). The Commission requires the following information:

a. Requests for long-term number portability in areas inside or outside the 100 largest MSAs: Long-term number portability must be provided by LECs and CMRS providers inside the 100 largest Metropolitan Statistical Areas (MSAs) in switches for which another carrier has made a specific request for number portability, according to the Commission's deployment schedule. After the deadline for deployment in an MSA, carriers must deploy number portability in additional switches in that MSA upon request within certain time frames. After December 31, 1998, for LECs and after November 24, 2002, for CMRS providers outside the 100 largest MSAs, the First Report and Order continues to require deployment within six months after a specific request by another telecommunications carrier. The request must specifically request long-term number portability, identify the area covered by the request, and provide a tentative date six or more months in the future when the carrier expects to need number portability in order to port prospective customers. See 47 CFR Sections 52.23(b) and 52.31(a). In a Memorandum Opinion and Order, in CC Docket No. 95-116, the Commission extended the deadline for CMRS providers to support service provider LNP in the top 100 MSAs until November 24, 2002. (Number of respondents: 210; hours per response: 3 hours; total annual burden: 630 hours).

b. Petitions to extend implementation deadline: Carriers that are unable to meet the deadlines for implementing a long-term number portability solution are required to file with the Commission at least 60 days in advance of the deadline a petition to extend the time by which implementation in its network will be completed. See 47 CFR Sections 52.23(3) and 52.31(d). (No. of respondents: 8; hours per response: 10 hours; total annual burden: 80 hours).

c. Tariffs and Cost Support: Incumbent LECs may recover their carrier-specific costs directly related to providing long-term number portability by establishing in tariffs filed with the Commission for a monthly number portability charge. See 47 CFR 52.33. Incumbent LECs are required to include many details in their cost support that are unique to the number portability proceeding pursuant to the Cost Classification Order. For instance, incumbent LECs must demonstrate that any incremental overhead costs claimed in their cost support are actually new costs incremental to and resulting from the provision of long-term number portability. (No. of respondents: 67; hours per response: 85.5 hours; total annual hours: 5728.5 hours).

d. Recordkeeping Requirement: Telecommunications carriers are required to provide information about their international and regional end-user telecommunications revenues that will enable the regional database administrator to allocate the costs of the number portability regional databases in a competitively neutral manner. See 47 CFR Sections 52.32 and 52.33. Incumbent LECs are also required to maintain records that detail both the nature and specific amount of these carrier-specific costs that are directly related to number portability, and those carrier-specific costs that are not directly related to number portability. See the Third Report and Order, CC Docket No. 95-116, released May 12, 1998. (No. of respondents: 1400; hours per response: 2 hours; total annual hour: 2800 hours).

The information collected and required by the Commission will be used to implement Section 251 of the Communications Act of 1934, as amended. Obligation to respond: Required to obtain or retain benefits.

Description: In CC Dockets No. 96-149 and 96-61, the Commission imposed recordkeeping requirements on independent LECs. Independent LECs wishing to offer international, interexchange services must comply with the separate affiliate requirements of the Competitive Carrier Fifth Report and Order in order to do so. One of these requirements is that the independent LEC's international, interexchange affiliate must maintain books of account separate from such LECs' local exchange and other activities. This regulation does not require that the affiliate maintain books of account that comply with the Commission's Part 32 rules; rather, it refers to the fact that as a separate legal entity, the international, interexchange affiliate must maintain its own books of account in the ordinary course of its business. This recordkeeping requirement is used by the Commission to ensure that independent LECs providing international, interexchange services through a separate affiliate are in compliance with the Communications Act, as amended, and with Commission policies and regulations. Obligation to respond: Mandatory.

OMB Control No.: 3060-0710.

Expiration Date: August 31, 2003.

Title: Policy and Rules Concerning the Implementation of the Local Competition Provisions of the Telecommunications Act of 1996—CC Docket 96-98.

Frequency of Response: On occasion; Recordkeeping; Third Party Disclosure.

Description: The Commission adopted rules and regulations to implement parts of 47 USC sections 251 and 252 that affect local competition. Incumbent local exchange carriers (LECs) are required to offer interconnection, unbundled network elements, transport and termination, and wholesale rates for certain services to new entrants. Incumbent LECs must price such services at rates that are cost-based and just and reasonable and provide access to rights-of-way as well as establish reciprocal compensation arrangements for the transport and termination of telecommunications traffic.

b. Submission of Agreements to the State Commission. Carriers must file interconnection agreements negotiated or arbitrated under the 1996 Act with the appropriate state commissions. Carriers must also file their existing interconnection agreements, including those with neighboring local exchange carriers (LECs), with the appropriate state commissions, according to schedules imposed by state commissions. Agreements between Class A carriers must be submitted to the state commission no later than June 30, 1997 or such earlier date as a state commission may require. Once agreements are approved by the state commission, incumbent LECs are also required to make provisions of their approved agreements available to all parties. 47 USC 252(e)(1), 252(i). See also 47 CFR Sections 51.100, 51.3, 51.303. (No. of respondents: 551; hours per response: 1.5 hours (avg.).; total annual burden: 835 hours).

c. Burden of Proof Regarding Interconnection and Access to Unbundled Network Elements. An incumbent LEC may be required to provide information to state commissions to prove that a particular interconnection or access point to unbundled network elements is not technically feasible. An incumbent LEC that denies a request to combine network elements must prove by clear and convincing evidence that the requested combination is not technically feasible or that the requested combination would impair the ability of other carriers to interconnect or to access unbundled network elements. 47 USC 251(c)(2), (c)(3). See also CFR Sections 51.305, 51.323. (No. of respondents: 100; hours per response: 250 hours; total annual burden: 25,000 hours).

d. Collocation. When an incumbent LEC alleges that there are space constraints, it must provide the state commission with detailed floor plans or diagrams of those premises. When an incumbent LEC objects to collocation of equipment by a telecommunications carrier, the incumbent LEC bears the burden of demonstrating to the state commission that the equipment will not be actually used for the purpose of obtaining interconnection or gaining access to unbundled network elements. An incumbent LEC providing collocation must permit interconnection of copper or coaxial cable if such interconnection is first approved by the state commission. 47 USC 251(c)(6). See also 47 CFR Sections 51.321, 51.323. (No. of respondents: 100; hours per response: 25 hours; total annual burden: 25,000 hours).

e. Notification that a State Commission Has Failed to Act. Any interested party seeking preemption of a state commission's jurisdiction based on the state commission's failure to act shall notify the Commission as follows: (1) file with the Secretary of the Commission a detailed petition, supported by an affidavit, that states with specificity the basis for any claim that it has failed to act; (2) serve the state commission and other parties to the proceeding on the same day that the party serves the petition on the Commission; and (3) within 15 days of the filing of the petition, the state commission and parties to the proceeding may file a response to the petition. 47 USC 252(e). See also 47 CFR Section 51.803. (No. of respondents: 30; hours per response: 1 hour; total annual burden: 30 hours).

f. Rural and Small Carriers. Rural and small carriers may have to submit information to state commissions in order to (1) justify a continued exemption under section 251(f)(1) once a bona fide request has been made; and (2) petition a state commission for a suspension or modification of the Act's requirements under section 251(f)(2). 47 USC 251(f). See also 47 CFR Section 51.403. (No. of respondents: 500 hours; hours per response: 10 hours; total annual burden: 5000 hours).

g. Pole Attachment Modifications. Absent a private agreement establishing notification procedures, utilities must provide no less than 60 days' written notification of a modification of a pole attachment to parties holding attachments on the facility to be modified. Notice should be sufficiently specific to apprise the recipient of the nature and scope of the planned modification. If the contemplated modification involves an emergency situation for which advanced written notice would prove impractical, the notice requirement does not apply, except that notice should be given as soon as reasonably practicable, which in some cases may be after the modification is completed. This requirement does not apply to routine pole maintenance activities. Utilities and parties with attachments should exchange maintenance handbooks or other written descriptions of their standard maintenance practices. Changes to these practices should be made only upon 60 days' written notice. 47 USC § 224(h). See also 47 CFR Section 1.1403. (No. of respondents: 12,250; hours per response: .50 hours; total annual burden: 531,125 hours).

h. Pole Attachment Access Requests and Denials of Access. The Commission adopts procedures to provide a complete record of pole access requests and denials of requests. Therefore, cable operators and telecommunications carriers must provide written requests for access to utilities. If access is not granted within 45 days of the request, the utility must confirm the denial in writing by the 45th day. The denial must be specific, and the utility must include all relevant evidence supporting its denial. It must enumerate how the evidence relates to one of the reasons that access can be denied under Section 224(f)(2), i.e., lack of capacity, safety, reliability or engineering standards. 47 USC 224(f), 251(b)(4). See also CFR Section 1.1403. (No. of respondents: 2750; hours per response: 1.18 hours (avg.).; total annual burden: 3250 hours).

i. Dispute Resolution Process for Denials of Access. Upon the receipt of a notice of denial from the utility, the requesting party shall have 60 days to file its complaint with the Commission. We anticipate that by following the required procedure for denials of access, the Commission will, upon receipt of a complaint, have all relevant information upon which to make its decision. The petition must be served pursuant to Section 1.1404(b) of the Commission's rules. 47 USC 224(f), 251(b)(4). See also CFR Sections 1.1403, 1.1404. (No. of respondents: 500; hours per response: 14.5 hours; total annual burden: 7250 hours).

k. Preparation of a Cost Study on Avoidable Costs to Determine Resale Discounts. States may prepare themselves, or require parties to prepare, avoided cost studies to determine resale discounts. Initially, a state may choose a percentage within the Commission's default discount percentage range, or set a discount through review of an avoided cost study prepared by a state or a party. A state that chooses to employ the Commission's default discount percentage range must articulate a reason for its choice, and must set a resale discount through review of an avoided cost study within a reasonable time after choosing the default percentage. 47 U.S.C. 251(c)(4), 252(d)(3). See also 47 CFR Sections 51.609, 51.611. (No. of respondents: 200; hours per response: 480 hours; total annual burden: 96,000 hours).

n. Filing Required for Arbitration. Parties must provide documentation to states (or the Commission acting under 252(e)(5)) when arbitration is to occur. This information will consist of a statement of unresolved issues and the positions of the parties with respect to those issues, and a list of other issues discussed and resolved by the parties. 47 U.S.C. 252(b)(2).

o. Determination of Rates for Interconnection, Unbundled Network Elements, and Transport and Termination of Telecommunications Traffic—State Commission Review of Forward-Looking Economic Cost Studies. The statute provides that during an arbitration the state commission shall set prices for interconnection, unbundled network elements, and transport and termination of telecommunications traffic. The state commission sets such prices either through review of a forward-looking economic cost study, or by choosing one of the Commission's proxies. 47 U.S.C. 251(b), (c)(2), (c)(3), (c)(6), 252(d)(1). See also 47 CFR Section 51.507, 51.503, 51.505. (No. of respondents: 50; hours per response: 2160 hours; total annual burden: 108,000 hours).

p. Determination of Resale Discount Percentage—State Commission Review of Avoided Cost Studies. The statute provides that during an arbitration, the state commission shall set the percentage discount for resale of telecommunications services. Initially, a state may choose a discount percentage within the Commission's default discount percentage range, or set a discount through review of an avoided cost study prepared by a state or a party. A state that chooses to employ the Commission's default discount percentage range must set a resale discount through review of an avoided cost study within a reasonable time after choosing the default percentage. 47 U.S.C. 251(c)(4), 252(d)(3). See also 47 CFR Section 51.611. (No. of respondents: 50; hours per response: 640 hours; total annual burden: 32,000 hours).

q. Petition for Incumbent LEC Status. A state commission, or any other interested party, may request that the Commission issue an order declaring that a particular LEC be treated as an incumbent LEC, or that a class or category of LECs be treated as incumbent LECs. 47 U.S.C. 251(h)(2). (No. of respondents: 30; hours per response: 1 hour; total annual burden: 30 hours).

r. Use of Proxies by State Commissions—Articulating Written Reasons for Choice. State commissions may set rates for interconnection, unbundled network elements, transport and termination of telecommunications traffic, and resale utilizing a proxy or default percentage as an alternative to conducting or reviewing a cost study. In the First Order on Reconsideration, the Commission created a proxy to assist state commissions in setting rates for the flat-rated component of the local switching network element. If a state commission chooses this option, it must articulate written reasons for its choice. 47 USC 251(b)(5), (c)(2), (c)(3), (c)(4), (c)(6), 252(d)(1), (d)(2), (d)(3). See also 47 CFR Sections 51.503, 51.505. (No. of respondents: 50; hours per response: 120 hours; total annual burden: 6000 hours).

s. Preparation of Forward-looking Economic Cost Studies to Establish Rates for Transport and Termination for Paging and Radiotelephone Service, Narrowband Personal Communications Services, and Paging Operations in the Private Land Mobile Radio Services. A state commission shall establish the rates that licensees in the Paging and Radiotelephone Service, Narrowband Personal Communications Services, and Paging Operations in the Private Land Mobile Radio Services may charge to other carriers for transport and termination of traffic, to the extent these carriers are unable to reach agreement on transport and termination rates in their interconnection agreements. Such rates must be based on forward-looking economic costs, and may not be set utilizing a proxy. Given the lack of information in the record concerning paging providers' costs, the Commission was unable to set a proxy for transport and termination rates for use by these carriers. 47 U.S.C. 251(b)(5). See also 47 CFR Sections 20.11, 51.505, 51.513. (No. of respondents: 50; hours per response: 720 hours; total annual burden: 36,000 hours). All of the requirements would be used to ensure that respondents comply with their obligations under the Telecommunications Act of 1996. Obligation to respond: Mandatory.

Public reporting burden for the collection of information is as noted above. Send comments regarding the burden estimate or any other aspect of the collections of information, including suggestions for reducing the burden to Performance Evaluation and Records Management, Washington, DC 20554.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

DATES:

Written comments should be submitted on or before October 19, 2000. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

For additional information or copies of the information collections contact Les Smith at (202) 418-0217 or via the Internet at lesmith@fcc.gov.

SUPPLEMENTARY INFORMATION:

OMB Control Number: 3060-0743.

Title: Implementation of the Pay Telephone Reclassification and Compensation Provisions of the Telecommunications Act of 1996, CC Docket No. 96-128.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 3,342.

Estimate Time Per Response: 0.5 to 100 hours.

Frequency of Response: Recordkeeping; On occasion, quarterly, annual, and one-time reporting requirements; Third party disclosure.

Total Annual Burden: 131,077 hours.

Total Annual Costs: None.

Needs and Uses: The FCC's CC Doc. No. 96-128 promulgated rules and requirements implementing Section 276 of the Telecommunications Act of 1996. Among other things, the rules: (1) Establish fair compensation for every completed intrastate and interstate payphone call; (2) discontinue intrastate and interstate carrier access charge payphone service elements and payment, and intrastate and interstate payphone subsidies from basic exchange services; and (3) adopt guidelines for use by the states in establishing public interest payphone in locations where payphones might not otherwise be located. Thus, the requirements in the Report and Order ensure that interexchange carriers, payphone service providers, LECs, and the states comply with their obligations under the Telecommunications Act of 1996, as amended.

OMB Control Number: 3060-0561.

Title: Section 76.913, Assumption of Jurisdiction by the Commission.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: State, Local, or Tribal Government.

Number of Respondents: 50.

Estimate Time Per Response: 8 hours.

Frequency of Response: On occasion reporting requirements.

Total Annual Burden: 400 hours.

Total Annual Costs: None.

Needs and Uses: 47 CFR 76.913 permits a local franchising authority (LFA) that is unable to meet certification standards to petition the Commission to regulate the basic service cable rates of its franchisee. The Commission uses the information collected under this requirement to identify situations where it should exercise jurisdiction over basic service and equipment rates in place of an LFA. Without this information, the basic cable rates of some franchising areas which are not subject to effective competition would remain unregulated in contravention of the goals of the 1992 Cable Act.

Respondents: Business or other for-profit entities; State, Local, or Tribal Government.

Number of Respondents: 300.

Estimate Time Per Response: 1.0 hours.

Frequency of Response: On occasion reporting requirements.

Total Annual Burden: 300 hours.

Total Annual Costs: None.

Needs and Uses: The Commission uses the information in this collection to ensure that franchising authority decisions regarding cable rates are consistent with the provisions of the Cable Television Consumer Protection and Competition Act of 1992 and the Commission's rules regarding cable rate regulation. The Commission's review of appeals is necessary to ensure uniformity of interpretation of Federal guidelines.

Respondents: Business or other for-profit entities; and State, Local, or Tribal Government.

Number of Respondents: 4,475.

Estimate Time Per Response: 1 to 12 hours.

Frequency of Response: On occasion reporting requirements.

Total Annual Burden: 9,150 hours.

Total Annual Costs: None.

Needs and Uses: 47 CFR 76.922, in relevant part, provides that cable operators may adjust their permissible rates to reflect the rate they would be charging if they had been permitted to include increases in external costs occurring between September 30, 1992, and their initial date of regulation reduced by inflation increases already received with respect to those costs. This section also provides that qualified small systems using the streamlined rate reduction process must notify subscribers, the LFA, and the FCC, and it allows such small systems to increase rates to recover the costs of headend upgrades. The Commission uses the information in this collection to ensure that qualified small systems have additional incentives to add channels and that small systems are able to recover costs for headend upgrades when doing so.

The following items have been deleted from the list of agendas items scheduled for consideration at the September 14, 2000, Open Meeting and previously listed in the Commission's Notice of September 7, 2000.

Summary: The Commission will consider a First Report and Order and Further Notice of Proposed Rule Making in WT Docket No. 99-217, a Fourth Report and Order and Memorandum Opinion and Order in CC Docket No. 96-98, and a Memorandum Opinion and Order in CC Docket No. 88-57), regarding obstacles to consumer's choice of telecommunications providers in multiple tenant environments.

The meeting will be open to the public (except as noted above) with seating available on a first-come, first-served basis. Members of the general public who plan to attend the meeting should contact the Office of the Superintendent, National Fire Academy, U.S. Fire Administration, 16825 South Seton Avenue, Emmitsburg, MD 21727, (301) 447-1117, on or before September 29, 2000.

Minutes of the meeting will be prepared and will be available for public viewing in the Office of the Chief Operating Officer, U.S. Fire Administration, Federal Emergency Management Agency, Emmitsburg, Maryland 21727. Copies of the minutes will be available upon request within 60 days after the meeting.

The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than October 4, 2000.

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/.

Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 13, 2000.

In connection with this application, USAccess Holdings, Inc., Louisville, Kentucky; to become a bank holding company by acquiring at least 66 percent of the voting shares of USAccess Bank, Inc. (an existing subsidiary bank of Porter Bancorp), Louisville, Kentucky.

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/.

Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 4, 2000.

Board of Governors of the Federal Reserve System, September 14, 2000. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 00-24029 Filed 9-18-00; 8:45 am] BILLING CODE 6210-01-PFEDERAL RESERVE SYSTEM Notice of Proposals To Engage in Permissible Nonbanking Activities or to Acquire Companies That Are Engaged in Permissible Nonbanking Activities

The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.

Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/.

Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 13, 2000.

1. Allegiant Bancorp, Inc., St. Louis, Missouri; to acquire Equality Bancorp, Inc., St. Louis, Missouri, thereby indirectly acquiring its wholly owned thrift subsidiary, Equality Savings Bank, St. Louis, Missouri, and thereby engage in owning and operating a savings association, pursuant to § 225.28(b)(4)(ii) of Regulation Y. Comments regarding this application must be received not later than October 13, 2000.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for exemption from the food additive listing regulation requirements.

DATES:

Submit written or electronic comments on the collection of information by November 20, 2000.

ADDRESSES:

Submit electronic comments on the collection of information via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/edockethome.cfm. Submit written comments on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Threshold of Regulation for Substances used in Food-Contact Articles—21 CFR 170.39 (OMB Control Number 0910-0298)—Extension

Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe unless: (1) It conforms to an exemption for investigational use under 409(j); (2) it conforms to the terms of a regulation prescribing its use; or (3) in the case of a food additive which meets the definition of a food-contact substance in section 409(h)(6), there is either a regulation authorizing its use in accordance with section 409(a)(3)(A) or an effective notification in accordance with section 409(a)(3)(B).

In the Federal Register of July 17, 1995 (60 FR 36582), § 170.39 (21 CFR 170.39) established a process that provides the manufacturer with an opportunity to demonstrate that the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification. The agency has established two thresholds for the regulation of substances used in food-contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 parts per billion. The second exempts regulated direct food additives for use in food-contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances.

In order to determine whether the intended use of a substance in a food-contact article meets the threshold criteria, certain information specified in § 170.39(c) must be submitted to FDA. This information includes: (1) The chemical composition of the substance for which the request is made; (2) detailed information on the conditions of use of the substance; (3) a clear statement of the basis for the request for exemption from regulation as a food additive; (4) data that will enable FDA to estimate the daily dietary concentration resulting from the proposed use of the substance; (5) results of a literature search for toxicological data on the substance and its impurities; and (6) information on the environmental impact that would result from the proposed use.

FDA uses this information to determine whether the food-contact article meets the threshold criteria. Respondents to this information collection are individual manufacturers and suppliers of substances used in food-contact articles (i.e., food packaging and food processing equipment) or of the articles themselves.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden 121 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Hours 170.396 1 6 48 288 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The above annual reporting estimate is based on information received from representatives of the food packaging and processing industries and on agency records. In the past, FDA has typically received 60 threshold of regulation exemption requests per year. However, it is estimated that up to 90 percent of the requests that would have previously been submitted under § 170.39 will now be submitted under the premarket notification process for food-contact substances established by section 409(h) of the act.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on orphan drugs.

DATES:

Submit written or electronic comments on the collection of information by November 20, 2000.

ADDRESSES:

Submit electronic comments on the collection of information via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/edockethome.cfm. Submit written comments on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Orphan Drugs, 21 CFR Part 316 (OMB No. 0910-0167)—Reinstatement

Sections 525 through 528 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aa through 360dd) give FDA statutory authority to: (1) Provide recommendations on investigations required for approval of marketing applications for orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set forth conditions under which a sponsor of an approved orphan drug obtains exclusive approval, and (4) encourage sponsors to make orphan drugs available for treatment on an “open protocol” basis before the drug has been approved for general marketing. The implementing regulations for these statutory requirements have been codified under part 316 (21 CFR part 316) and specify procedures that sponsors of orphan drugs use in availing themselves of the incentives provided for orphan drugs in the act and sets forth procedures FDA will use in administering the act with regard to orphan drugs. Section 316.10 specifies the content and format of a request for written recommendations concerning the nonclinical laboratory studies and clinical investigations necessary for approval of marketing applications. Section 316.12 provides that, before providing such recommendations, FDA may require results of studies to be submitted for review. Section 316.14 contains provisions permitting FDA to refuse to provide written recommendations under certain circumstances. Within 90 days of any refusal, a sponsor may submit additional information specified by FDA. Section 316.20 specifies the content and format of an orphan drug application which includes requirements that an applicant document that the disease is rare (affects fewer than 200,000 persons in the United States annually) or that the sponsor of the drug has no reasonable expectation of recovering costs of research and development of the drug. Section 316.26 allows an applicant to amend the application under certain circumstances. Section 316.30 requires submission of annual reports, including progress reports on studies, a description of the investigational plan, and a discussion of changes that may affect orphan status. The information requested will provide the basis for an FDA determination that the drug is for a rare disease or condition and satisfies the requirements for obtaining ophan drug status. Secondly, the information will describe the medical and regulatory history of the drug. The respondents to this collection of information are biotechnology firms, drug companies, and academic clinical researchers.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden 121 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response

Total Hours 316.10, 316.12, and 316.1400000 316.20, 316.21, and 316.26901.78160.2012520,025 316.22515210 316.27515420 316.3045014502900 316.36.23.6159 Total burden hours20,964 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The information requested from respondents represents, for the most part, an accounting of information already in possession of the applicant. It is estimated, based on the frequency of requests over the past 10 years, that 90 persons or organizations per year will request orphan drug designation and that no requests for recommendations on design of preclinical or clinical studies will be received. Based upon FDA experience over the last decade, FDA estimates that the effort required to prepare applications to receive consideration for sections 525 and 526 of the act (§§ 316.10, 316.12, 316.20, and 316.21) is generally similar and is estimated to require an average of 95 hours of professional staff time and 30 hours of support staff time per application. Estimates of annual activity and burden for foreign sponsor nomination of a resident, agent, change in ownership or designation, and inadequate supplies of drug in exclusivity, are based on total experience by FDA with such requests since 1983.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Administrative Detention and Banned Medical Devices” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In the Federal Register of March 31, 2000 (65 FR 17282), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0114. The approval expires on August 31, 2003. A copy of the supporting statement for this information collection is available on the Internet at “http://www.fda.gov/ohrms/dockets”.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), announcement is made of the following National Advisory body scheduled to meet during the month of October 2000.

The following applicants have applied for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531, et seq.):

Applicant: Wendell Fairbanks, Hastings, ND, PRT-029691.

The applicant requests a permit to import the sport-hunted trophy of one male bontebok (Damaliscus pygargus dorcas) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species.

Applicant: David P. Johnson, Miduahe, UT, PRT-032827.

The applicant requests a permit to import the sport-hunted trophy of one male bontebok (Damaliscus pygargus dorcas) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species.

Applicant: Bruce Taylor, Columbia, SC, PRT-032825.

The applicant requests a permit to import the sport-hunted trophy of one male bontebok (Damaliscus pygargus dorcas) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species.

Applicant: Brigham Young University, Provo, UT, PRT-006998.

The applicant amends an request for a permit to import tissue samples and voucher specimens of wild Giant Amazon River turtles (Podocnemis expansa) and Yellow-Spotted River turtles (Podocnemis unifilis) from Brazil to include Venezuela and Peru. The previous notification appeared in Federal Register Notice Vol. 64, No. 242. This notification covers activities conducted by the applicant over a five year period.

Written data or comments should be submitted to the Director, U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203 and must be received by the Director on or before October 19, 2000.

Marine Mammals

The public is invited to comment on the following application for a permit to conduct certain activities with marine mammals. The application was submitted to satisfy requirements of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.) and the regulations governing marine mammals (50 CFR 18).

Name and Number of Animals: Southern and Northern Sea Otters. (Enhydra lutris lutris and Enhydra lutris nereis); Up to 15 animals from California and up to 40 animals from Alaska, 0.5 to 1.0 gram liver biopsy samples.

Summary of Activity to be Authorized: The applicant requests an amendment to their permit to collect liver biopsy samples for scientific research purposes to determine estimates of contaminants exposure. At the time of previously permitted surgical procedures, a liver sample will be removed by sterile scalpel.

Source of Marine Mammals: As described above and in current permit.

Period of activity: Until February, 2002.

Concurrent with the publication of this notice in the Federal Register, the Division of Management Authority is forwarding copies of the application listed above to the Marine Mammal Commission and the Committee of Scientific Advisors for their review.

Written data or comments should be submitted to the Director, U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203 and must be received by the Director within 30 days of the date of this publication.

Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents to the following office on or before October 19, 2000: U.S. Fish and Wildlife Service, Office of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203. Phone: (703/358-2104); FAX: (703/358-2281).

The following applicants have applied for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(a) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531, et seq.).

Permit No. TE-28605

Applicant: SWCA, Flagstaff, Arizona.

Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the following endangered species in Arizona and New Mexico:

Applicant requests authorization for recovery purposes to conduct presence/absence surveys for the southwestern willow flycatcher (Empidonax traillii extimus) in various counties in New Mexico.

DATES:

Written comments on these permit applications must be received on or before October 19, 2000.

ADDRESSES:

Written data or comments should be submitted to the Legal Instruments Examiner, Division of Endangered Species/Permits, Ecological Services, P.O. Box 1306, Albuquerque, New Mexico 87103. Please refer to the respective permit number for each application when submitting comments. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public.

FOR FURTHER INFORMATION CONTACT:

The U.S. Fish and Wildlife Service, Ecological Services, Division of Endangered Species/Permits, P.O. Box 1306, Albuquerque, New Mexico 87103. Please refer to the respective permit number for each application when requesting copies of documents. Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents within 30 days of the date of publication of this notice, to the address above.

We, the U.S. Fish and Wildlife Service, announce the availability for public review of a draft recovery plan for the robust spineflower (Chorizanthe robusta var. robusta) from Santa Cruz County, California. This federally endangered plant taxon is known from four coastal and near-coastal sites in Santa Cruz County, California. We solicit review and comment from local, State, and Federal agencies, and the public on this draft recovery plan.

DATES:

Comments on the draft recovery plan must be received on or before November 20, 2000, to receive our consideration.

ADDRESSES:

Copies of the draft recovery plan are available for inspection, by appointment, during normal business hours at the following location: U.S. Fish and Wildlife Service, 2493 Portola Road, Suite B, Ventura, California 93003 (phone: 805/644-1766). The draft recovery plan will also be available at the Santa Cruz Public Library. Requests for copies of the draft recovery plan and written comments and materials regarding this plan should be addressed to Ms. Diane K. Noda, Field Supervisor, at the above Ventura address.

Restoring endangered or threatened animals and plants to the point where they are again secure and self-sustaining members of their ecosystems is a primary goal of our endangered species program. To help guide the recovery effort, we are working to prepare recovery plans for most of the federally listed species native to the United States. Recovery plans describe actions considered necessary for the conservation of the species, establish criteria for recovery levels to downlist or delist them, and estimate time and cost for implementing the recovery measures needed.

The Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.) (Act), requires the development of recovery plans for federally listed species unless such a plan would not promote the conservation of a particular species. Section 4(f) of the Act requires that public notice and an opportunity for public review and comment be provided during recovery plan development. We will consider all information presented during the public comment period prior to approval of each new or revised recovery plan. Substantive technical comments will result in changes to the plans. Substantive comments regarding recovery plan implementation may not necessarily result in changes to the recovery plans, but will be forwarded to appropriate Federal or other entities so that they can take these comments into account during the course of implementing recovery actions. Individualized responses to comments will not be provided.

The robust spineflower is federally listed as endangered. The robust spineflower is restricted to sandy soils along the coast and near-coastal areas in Santa Cruz County, California from Santa Cruz south to Sunset State Beach. It is currently known from four sites. The first site, Pogonip Park, supports two small colonies; the Park is owned and managed by the City of Santa Cruz. The second site is Sunset Beach State Park; a large population is scattered along approximately 1 kilometer (0.5 mile) of backdune habitat. The third site is on a 115-hectare (285-acre) private parcel known as Buena Vista that has been considered for golf course development; small colonies are scattered over 4 hectares (10 acres). The fourth site, located near Rob Roy Junction, is on a 8-hectare (20-acre) private parcel that was recently proposed for a lot split; the population here is scattered over 1.2 hectares (3 acres).

The objective of this draft recovery plan is to provide a framework for delisting the robust spineflower so that protection by the Act is no longer necessary. Actions necessary to accomplish this objective include: Protect robust spineflower habitat through land acquisition, conservation easements, and Habitat Conservation Plans; managing robust spineflower habitat; conduct management-oriented research on the taxon's ecology and biology; review and revise management and recovery plan guidelines; locate additional populations; and establish new populations of the taxon within the historic range of this variety of Chorizanthe robusta.

Authority:

The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f).

Dated: September 13, 2000.Elizabeth H. Stevens,Acting Manager, California/Nevada Operations Office, Region 1, U.S. Fish and Wildlife Service.[FR Doc. 00-23996 Filed 9-18-00; 8:45 am]BILLING CODE 4310-55-MDEPARTMENT OF THE INTERIOR Fish and Wildlife Service Availability of a Habitat Conservation Plan and Receipt of an Application for an Incidental Take Permit for the Westwood Tributary Point Office Project, Sacramento County, California AGENCY:

Fish and Wildlife Service, Interior.

ACTION:

Notice of availability and receipt of application.

SUMMARY:

Westwood Tributary Point Limited (Applicant) has applied to the Fish and Wildlife Service (Service) for an incidental take permit pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act). The Service proposes to issue a 2-year permit to the Westwood Tributary Point Limited that would authorize take of the threatened valley elderberry longhorn beetle (Desmocerus californicus dimorphus) incidental to otherwise lawful activities. Such take would occur as a result of development on the Westwood Tributary Point Office Project area in Sacramento County, California. Development will result in the loss of one elderberry plant with two stems which provide habitat for the valley elderberry longhorn beetle.

We request comments from the public on the permit application, which is available for review. The application includes a Habitat Conservation Plan (Plan). The Plan describes the proposed project and the measures that Westwood Tributary Point Limited would undertake to minimize and mitigate take of the valley elderberry longhorn beetle.

We also request comments on our preliminary determination that the Plan qualifies as a “low-effect” Habitat Conservation Plan, eligible for a categorical exclusion under the National Environmental Policy Act. The basis for this determination is discussed in an Environmental Action Statement, which is also available for public review.

DATES:

Written comments should be received on or before October 19, 2000.

ADDRESSES:

Send written comments to Mr. Wayne White, Field Supervisor, Fish and Wildlife Service, 2800 Cottage Way, Suite W-2605, Sacramento, California 95825-1846. Comments may be sent by facsimile to 916-414-6712 or 6713.

Please contact the above office if you would like copies of the application, Plan, and Environmental Action Statement. Documents also will be available for review by appointment, during normal business hours at the above address.

Background

Section 9 of the Endangered Species Act and Federal regulation prohibit the “take” of fish or wildlife species listed as endangered or threatened, respectively. Take of listed fish or wildlife is defined under the Act to include kill, harm, or harass. The Service may, under limited circumstances, issue permits to authorize incidental take; i.e., take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity. Regulations governing incidental take permits for threatened and endangered species are found in 50 CFR 17.32 and 17.22, respectively.

The Westwood Tributary Point Office project is located west of Hazel Avenue, south of Folsom South Canal, and north of U.S. Highway 50 in the unincorporated Rancho Cordova area of Sacramento County. The project site is one parcel of a larger development area, which corresponds to an un-sectioned portion of Township 9 North, Range 7 East of the United States Geological Survey “Folsom, California” topographic quadrangle. The Applicant is requesting a 2-year incidental take permit for the valley elderberry longhorn beetle.

The Westwood Tributary Point Office project area is currently a partially graded vacant lot. The applicant plans on erecting a 2-story 37,000-square-foot office building with parking facilities on the 3.43-acre site. Other land uses in the surrounding area include a 216-unit high-end apartment village, a 70,000-square-foot, 3-story office building, 2 retail furniture stores, 2 fast-food restaurants, and 2 gas station/convenience marts. Two additional lots are owned by an extended-stay hotel operator.

One small (6-foot-tall) blue elderberry (Sambucus mexicana) shrub is present on the property. Westwood Tributary Point Limited has submitted a Plan to minimize and mitigate for the removal (transplantation) of this plant, which is potential habitat for the valley elderberry longhorn beetle, federally listed as threatened under the Act. No beetle exit holes were found in this shrub. The project site does not contain any other rare, threatened, or endangered species or habitat. No critical habitat for any listed species occurs on the project site. Construction of the proposed project would result in the removal of one elderberry shrub with two stems greater than 1-inch diameter at ground level.

Under the Plan, compensation for impacts to the valley elderberry longhorn beetle would conform to the Service's 1999 Conservation Guidelines. The elderberry shrub affected by the proposed project would be transplanted to the Conservation Resources Laguna Creek Mitigation Bank, a Service-approved compensation site. Transplantation would occur after September 15, 2000 and prior to February 15, 2001. To fully comply with the Service's conservation guidelines for the transplantation of elderberry shrubs, and to minimize the effects of take on the beetle, Westwood Tributary Point Limited will purchase one valley elderberry longhorn beetle compensation unit at the Laguna Creek Mitigation Bank. Purchase of this compensation unit will result in the planting of five elderberry plants and five associated native plants to compensate for impacts to two stems. The purchase of this compensation unit will be consummated with an agreement for the sale of one valley elderberry longhorn beetle compensation unit between Westwood Tributary Point Limited and Conservation Resources, LLC.

The Service's Proposed Action consists of the issuance of an incidental take permit and implementation of the Plan, which includes measures to minimize and mitigate impacts of the project on the valley elderberry longhorn beetle. Two alternatives to the taking of listed species under the Proposed Action are considered in the Plan. Under the No Action Alternative, no permit would be issued. However, Westwood Tributary Point Limited did not select this alternative as it is inconsistent with local development goals and would result in the undisturbed elderberry shrub being left on the site in an isolated patch of open space with little habitat value. Another alternative would result in the development of another site instead of the described project site. The proposed project is an infill project and has minor or negligible environmental effects. Westwood Tributary Point Limited considers development of the present site as more desirable than construction of the project on an open site in a less-developed area because the use of an alternative site may result in greater environmental effects.

The Service has made a preliminary determination that the Plan qualifies as a “low-effect” plan as defined by its Habitat Conservation Planning Handbook (November 1996). Our determination that a habitat conservation plan qualifies as a low-effect plan is based on the following three criteria: (1) Implementation of the plan would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) implementation of the plan would result in minor or negligible effects on other environmental values or resources; and (3) impacts of the plan, considered together with the impacts of other past, present and reasonably foreseeable similarly situated projects would not result, over time, in cumulative effects to environmental values or resources which would be considered significant. As more fully explained in our Environmental Action Statement, Westwood Tributary Point Limited's habitat conservation plan for the Westwood Tributary Point Office Project qualifies as a “low-effect” plan for the following reasons:

1. Approval of the Plan would result in minor or negligible effects on the valley elderberry longhorn beetle and its habitat. The Service does not anticipate significant direct or cumulative effects to the valley elderberry longhorn beetle resulting from development of the Westwood Tributary Point Office Project.

2. Approval of the Plan would not have adverse effects on unique geographic, historic or cultural sites, or involve unique or unknown environmental risks.

3. Approval of the Plan would not result in any cumulative or growth inducing impacts and, therefore, would not result in significant adverse effects on public health or safety.

4. The project does not require compliance with Executive Order 11988 (Floodplain Management), Executive Order 11990 (Protection of Wetlands), or the Fish and Wildlife Coordination Act, nor does it threaten to violate a Federal, State, local or tribal law or requirement imposed for the protection of the environment.

5. Approval of the Plan would not establish a precedent for future action or represent a decision in principle about future actions with potentially significant environmental effects.

The Service therefore has made a preliminary determination that approval of the Plan qualifies as a categorical exclusion under the National Environmental Policy Act, as provided by the Department of the Interior Manual (516 DM 2, Appendix 1 and 516 DM 6, Appendix 1). Based upon this preliminary determination, we do not intend to prepare further National Environmental Policy Act documentation. The Service will consider public comments in making its final determination on whether to prepare such additional documentation.

The Service provides this notice pursuant to section 10(c) of the Endangered Species Act. We will evaluate the permit application, the Plan, and comments submitted thereon to determine whether the application meets the requirements of section 10 (a) of the Act. If the requirements are met, the Service will issue a permit to the Westwood Tributary Point for the incidental take of the valley elderberry longhorn beetle from development of the Westwood Tributary Point Office Project area. We will make the final permit decision no sooner than 30 days from the date of this notice.

Dated: September 8, 2000.Elizabeth H. Stevens,Deputy Manager, California/Nevada Operations Office, Sacramento, California.[FR Doc. 00-23970 Filed 9-18-00; 8:45 am] BILLING CODE 4130-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Receipt of an Application and Availability of an Environmental Assessment/Habitat Conservation Plan for Issuance of an Endangered Species Act 10(a)(1)(B) Permit for the Incidental Take of the Houston Toad (Bufo houstonensis) During Construction of a Recreational Vehicle Park and Camp Ground on Approximately 1.8 Acres of a 10.516-Acre Property on Park Road 1-C, Bastrop County, Texas SUMMARY:

Marion Kelly Walraven (Applicant) has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit pursuant to section 10(a) of the Endangered Species Act (Act). The Applicant has been assigned permit number TE-033185-0. The requested permit, which is for a period of 5 years, would authorize the incidental take of the endangered Houston toad (Bufo houstonensis). The proposed take would occur as a result of the construction and occupation of an approximately 1.8-acre recreational vehicle park and campground located along Park Road 1-C, Bastrop County, Texas.

The Service has prepared the Environmental Assessment/Habitat Conservation Plan (EA/HCP) for the incidental take application. A determination of jeopardy to the species or a Finding of No Significant Impact (FONSI) will not be made until at least 60 days from the date of publication of this notice. This notice is provided pursuant to section 10(c) of the Act and National Environmental Policy Act regulations (40 CFR 1506.6).

DATES:

Written comments on the application should be received on or before November 20, 2000.

ADDRESSES:

Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Albuquerque, New Mexico 87103.

Persons wishing to review the EA/HCP may obtain a copy by contacting Tannika Engelhard, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, Texas 78758 (512/490-0057). Documents will be available for public inspection by written request, by appointment only, during normal business hours (8:00 to 4:30) at the U.S. Fish and Wildlife Service, Austin, Texas. Written data or comments concerning the application and EA/HCP should be submitted to the Supervisor, U.S. Fish and Wildlife Service, Austin, Texas, at the above address. Please refer to permit number TE-033185-0 (Walraven) when submitting comments.

FOR FURTHER INFORMATION CONTACT:

Tannika Engelhard at the above U.S. Fish and Wildlife Service, Austin Office.

SUPPLEMENTARY INFORMATION:

Section 9 of the Act prohibits the “taking” of endangered species such as the Houston toad. However, the Service, under limited circumstances, may issue permits to take endangered wildlife species incidental to, and not the purpose of, otherwise lawful activities. Regulations governing permits for endangered species are at 50 CFR 17.22.

Applicant: Marion Kelly Walraven plans to construct a recreational vehicle park and campground on approximately 1.8 acres of the 10.516-acre property located on Park Road 1-C, Bastrop County, Texas. This action will eliminate 1.8 acres or less of Houston toad habitat and result in indirect impacts within the property. The Applicant proposes to compensate for this incidental take of the Houston toad by providing $7,200.00 to the National Fish and Wildlife Foundation for the specific purpose of land acquisition and management within Houston toad habitat, as identified by the Service.

Notice of availability of final environmental impact statement/report for the San Dieguito Lagoon Restoration Plan, San Diego County, California.

SUMMARY:

Pursuant to the National Environmental Policy Act of 1969, the Fish and Wildlife Service (FWS) announces the availability of a final environmental impact statement/report (FEIS/R) for the San Dieguito Lagoon Restoration Plan, San Diego County, California.

DATES:

A 30-day review period will follow the Environmental Protection Agency's notice of availability of the FEIS/R on September 15, 2000.

This FEIS/R has been prepared and is being circulated in accordance with the National Environmental Policy Act (NEPA). This project involves the proposal to implement a comprehensive habitat restoration plan with a public access component for an approximately 400-acre area known as the San Dieguito Lagoon. The project site is in the western San Dieguito River Valley under the influence of the Pacific Ocean, within the northwestern-most portions of the City of San Diego and the City of Del Mar in San Diego County, CA.

A major component of this planning effort is a tidal restoration proposal to: (1) Restore the aquatic functions of the lagoon through permanent inlet maintenance and expansion of the lagoon's tidal prism; and (2) create subtidal and intertidal habitats on both the east and west sides of Interstate 5, which bisects the project site. It is anticipated that tidal restoration would be accomplished primarily by Southern California Edison and partners (SCE), provided the restoration satisfies the conditions of the California Coastal Commission (CCC) permit for the construction and operation of the San Onofre Nuclear Generating Station (SONGS) Units 2 and 3. Upland habitat restoration, non-tidal wetland restoration, endangered species habitat improvements, and public trails and interpretive facilities would be provided by the San Dieguito River Park in cooperation with other agencies and organizations including the Fish and Wildlife Service, Coastal Conservancy, Cities of Del Mar and San Diego, and others.

The Final EIS/R analyzes six project alternatives including the Mixed Habitat, Maximum Tidal Basin, Maximum Intertidal, Hybrid, Reduced Berm, and No Action Alternatives. The lead agencies indicate a preference for the Mixed Habitat alternative. The project includes measures to mitigate some potential impacts, while other mitigation will be made conditions of subsequent permits.

On January 6,1998, a notice was published in the Federal Register, Vol. 63, No. 3, Page 570, that an application had been filed with the Fish and Wildlife Service by Arthur Cantando for a permit (PRT-837847) to import one polar bear (Ursus maritimus) trophy taken from the Lancaster Sound population, Canada for personal use.

Notice is hereby given that on August 29, 2000, as authorized by the provisions of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.) the Fish and Wildlife Service authorized the requested permit subject to certain conditions set forth therein.

Documents and other information submitted for these applications are available for review by any party who submits a written request to the U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Rm 430, Arlington, Virginia 22203; Phone (703) 358-2104 or Fax (703) 358-2281.

The Western Montana Resource Advisory Council will convene at 9:00 a.m., Thursday, October 5, 2000, at the Missoula Field Office, 3255 Fort Missoula Road, Missoula, Montana. Issues will include the Whitetail-Pipestone Travel Management Plan, the Bureau of Land Management's agreement with the Bureau of Reclamation to co-manage Canyon Ferry, and the Centennial Travel Management Plan. Meeting will end at 4:00 p.m.

The meeting is open to the public and written comments may be given to the Council. Oral comments may be presented to the Council at 11:30 a.m. The time allotted for oral comment may be limited, depending on the number of persons wishing to be heard. Individuals who plan to attend and need further information about the meeting, or who need special assistance, such as sign language or other reasonable accommodations, should contact Jean Nelson-Dean, Resource Advisory Coordinator, at the Butte Field Office, 106 North Parkmont, P.O. Box 3388, Butte, Montana 59702-3388, telephone 406-494-5059.

To comply with the Paperwork Reduction Act of 1995 (PRA), we are submitting to OMB for review and approval an information collection request (ICR) to conduct a new survey on “Labor Migration and the Deepwater Oil Industry.” We are also soliciting comments from the public on this ICR.

Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from the rulemaking record, which we will honor to the extent allowable by law. There may be circumstances in which we would withhold from the record a respondent's identity, as allowable by the law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.

FOR FURTHER INFORMATION CONTACT:

Alexis London, Rules Processing Team, telephone (703) 787-1600. For details on the proposed survey or to obtain a copy of the survey questions, you may contact Harry Luton, in the MMS Gulf of Mexico Regional Office, telephone (504) 736-2784.

SUPPLEMENTARY INFORMATION:

Title: Survey—Labor Migration and the Deepwater Oil Industry.

OMB Control Number: 1010-NEW.

Abstract: The Outer Continental Shelf (OCS) Lands Act, 43 U.S.C. 1331 et seq., requires the Secretary of the Interior to preserve, protect, and develop oil and gas resources in the OCS; make such resources available to meet the Nation's energy needs as rapidly as possible; balance orderly energy resources development with protection of the human, marine, and coastal environment; ensure the public a fair and equitable return on the resources offshore; and preserve and maintain free enterprise competition.

The OCS Lands Act (at 43 U.S.C. 1346, Environmental Studies) instructs the Secretary of the Interior to conduct studies to establish environmental information as he deems necessary and to monitor the human, marine, and coastal environments. The purpose of the studies is to provide time-series and data trend information which can be used to identify any significant changes in the quality and productivity of such environments, to establish trends in the areas studied and monitored, and to design experiments to identify the causes of such changes. This authority and responsibility are among those delegated to MMS.

MMS proposes to conduct a survey to examine the consequences of international labor on four port communities in southern Louisiana. The information collected will aid MMS in understanding the impact of foreign labor on the well-being of communities in southern Louisiana. The scientific information is needed to understand the concerns, fears, and desires of communities with respect to OCS activities, and it is necessary for successful operation of the OCS oil and gas program in the region.

Questions in the survey will address the respondent's historical ties to the oil and gas industry; current views about his/her community, impact of the presence of foreign-born immigrants in the four communities, and background and household information.

Responses are voluntary. No proprietary items or questions of a sensitive nature will be collected.

Frequency: This will be a one-time data collection activity.

Estimated Number and Description of Respondents: Approximately 200 randomly selected households in each of the four communities (800 respondents).

Estimated Annual Reporting and Recordkeeping “Hour” Burden: Approximately 25 minutes per survey for the primary data collection effort. Follow-up discussions, when held, will average approximately 20 minutes. The total annual burden is estimated at 340 hours (333 hours for primary survey + 7 hours for follow-up conversations).

Estimated Annual Reporting and Recordkeeping “Non-Hour Cost” Burden: We have identified no non-hour cost burdens to the respondents.

Comments: The PRA (44 U.S.C. 3501, et seq.) provides that an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Section 3506(c)(2)(A) of the PRA requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *” Agencies must specifically solicit comments to: (a) Evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) enhance the quality, usefulness, and clarity of the information to be collected; and (d) minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.

To comply with the public consultation process, on June 22, 2000, we published a Federal Register notice (65 FR 38852) with the required 60-day comment period announcing that we would submit this ICR to OMB for approval. We have received no comments in response to that initial notice. If you wish to comment in response to this notice, send your comments directly to the offices listed under the ADDRESSES section of this notice. The OMB has up to 60 days to approve or disapprove the information collection but may respond after 30 days. Therefore, to ensure maximum consideration, OMB should receive public comments by October 19, 2000.

A notice of proposed year-round closure at Fort Funston in the Golden Gate National Recreation Area was published in the Federal Register on July 18, 2000 (65 FR 44546), and amended on July 26, 2000 (65 FR 45988). The comment period closed on September 18, 2000. This document extends the comment period. Public comments on this notice must be received by October 6, 2000.

Notice of information collection under review: Application for naturalization.

The Department of Justice, Immigration and Naturalization Service (INS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on July 5, 2000 at 65 FR 41490, allowing for a 60-day public comment period. No comments were received by the INS on the proposed extension of the current information collection.

On June 28, 2000 at 65 FR 39926, the INS published a notice in the Federal Register allowing for a 60-day public review and comment period on a proposed revision to Form N-400. Numerous comments were received by the public on the proposed revision of the form and will be addressed in the submission of the information collection request to OMB. Until such clearance is approved by OMB, the INS is requesting an extension without change of the current information collection.

The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until October 19, 2000.This process is conducted in accordance with 5 CFR 1320.10.

Written comments and/or suggestions regarding the items contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Lauren Wittenberg, Department of Justice Desk Officer, 725 17th Street, NW., Room 10235, Washington, DC 20530; 202-395-4318.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Overview of this information collection:

(1) Type of information collection: Extension of currently approved collection.

(2) Title of the form/collection: Application for Naturalization.

(3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form N-400. Adjudications Division, Immigration and Naturalization Service.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals and households. The information collected is used by the INS to determine eligibility for naturalization.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 700,000 responses at 4 hours and 30 minutes (4.5 hours) per response.

(6) An estimate of the total public burden (in hours) associated with the collection: 3,031,000 annual burden hours.

If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please contact Richard A. Sloan (202-514-3291), Director, Policy Directives and Instructions Branch, Immigration and Naturalization Service, U.S. Department of Justice, Room 4034, 425 I Street, NW., Washington, DC 20536. Additionally, comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time may also be directed to Mr. Richard A. Sloan.

The Bureau of Prisons (BOP) will prepare a DEIS for a Contractor-Owned and Contractor-Operated private correctional facility(ies) to house sentenced criminal aliens. The BOP is facing unprecedented growth in its inmate population. As a result, low security federal correctional institutions will be especially impacted. The projected growth in the population of sentenced criminal aliens will further exacerbate these low security population demands.

The BOP will be soliciting for a Contractor-Owned and Contractor-Operated correctional facility(ies) to house approximately 4,500 low security, male, non U.S. citizen criminal aliens. Proposed facility(ies) may include construction of a new facility, expansion of an existing facility, or use of an existing facility. Twenty sites throughout Arizona and California have been identified by contractors and offered to the BOP for consideration. The proposed sites have been submitted by the following contractors:

Cornell Corrections: (1) 80 acres of vacant, undeveloped land located west of Rancho Road and north of Millux Road near the City of Arvin, CA; (2) 77 acres of vacant, undeveloped land located along the south side of State Highway (SH) 186 and approximately 1,300 feet west of Rex Allen Jr. Drive near the City of Willcox, AZ; (3) 80 acres of vacant, undeveloped land located west of Sunset Boulevard and the Central Main Channel approximately 600 feet north of Cole Road near the city of Calexico, CA; (4) 79.09 acres of vacant, unimproved western Mojave Desert land located north of the BNSF railroad right-of-way near the city of Barstow, CA; (5) 88.24 acres of undeveloped land located in Snowflake, AZ.

Dominion Correctional Properties: (1) 196.2 acres of land of which 36.2 acres is proposed for the location of a sewage treatment facility, located SE 1/4 of Section 15, T 19 N, R 18 W, of the Gila and Salt River Meridian near the city of Kingman, AZ.

Alternative Programs, Inc.: (1) 80 acre parcel of land located west of Avenue D, between County 23rd Street and County 24th Street in San Luis, AZ.

Wackenhut Corrections Corporation: (1) 72 acres of agricultural land located in the southwest corner of Scofield Avenue and the undeveloped Poso Avenue alignment in Wasco, CA; (2) 64 acres of vacant land located west of Lenwood Road, between Jasper and Agate Roads near Barstow, CA; (3) 160 acres of undeveloped land located at the northwest corner of Arica and La Palma Roads in Eloy, AZ.

Correctional Services Corporation: (1) Four adjacent parcels of land, totaling approximately 97 acres each. The site is bordered by Anchor Avenue to the east, Parlier Avenue to the north, Monson Avenue to the west and East Manning Avenue to the south, near the city of Orange Cove, CA. (2) 160 acres of agricultural land bordered by Clark Road to the east and beyond by an Imperial Irrigation District (IID) irrigation canal and alfalfa crops.

The site is bordered by a vacant parcel with abandoned wooden structures to the north and beyond by the Imperial County detention facility. A dirt road borders the site to the west with an IID drainage canal and alfalfa crops located beyond. The site is bordered by a dirt road to the south and beyond by alfalfa crops, approximately three miles south of El Centro, CA; (3) 21 acres of agricultural land located at the northeastern edge of the town of Florence, AZ; (4) 235 acres of agricultural land bordered on the west by an asphalt road and agricultural land. The site is bordered on the north and east by dirt roads, irrigation ditches, and agricultural land. Located immediately south of the southeast corner of the site is a narrow strip of land along South Carter Lane, three miles northeast of the town of Eloy, AZ; (5) 100 acres of land located on the Safford Municipal Airport property approximately five miles northeast of Safford, AZ; (6) 115 acres of land bordered by U.S. 191 on the west, East Cardinal Drive on the north, South Lonesome Lane and residences on the east, and residences and undeveloped land on the south, approximately 4.5 miles south of Safford in Lebanon, AZ; (7) 136 acres of agricultural land bordered by E. Adams Avenue to the north, a dirt road to the east, E. Summer Avenue to the south and E. Hill Avenue to the west, approximately 3 miles west of Orange Cove, CA.

Corrections Corporation of America: (1) 20 acres of land that consists of 12 separate buildings located about 3,500 feet southeast of the Gila River and approximately 3/4 miles northeast of the Town of Florence between U.S. Route 89 and Bowling Road, Florence, AZ.

Imperial County Sheriff's Department: (1) 80 acre site located along the south side of McCabe Road and adjacent to the west side of Sperber Road in the agricultural area south of the city of El Centro, CA.

City of Shafter: (1) 15.97 acres of land located 676 feet east of Beech Street on the north side of Los Angeles Street in the southeast area of the city of Shafter, CA.

Each proposed site submitted to the BOP is in response to the Commerce Business Daily Notice issued June 13th. The notice required potential offerors to submit a Phase I Environmental Survey conducted in accordance with the American Society for Testing and Materials, Standard Practice for Environmental Site Assessment Process. Also included as a “non-scope consideration” under Chapter 12 of the Standard Practice, are a delineation or identification of on-site wetlands, and an analysis of potential impacts to threatened or endangered species, or species of special status. In further evaluation of these sites, several aspects will receive detailed examination including utilities, traffic patterns, noise, cultural resources, threatened and endangered species and land uses. The BOP intends to award a firm-fixed price contract with award-fee incentives; a potential term of ten years consisting of a three-year base and seven one-year option periods; a performance-based statement of work based generally on the American Correctional Association Standards; and a management emphasis on contractor quality control. After publication of this notice, the BOP will issue a Request for Proposals (RFPs). Proposals may be offered for any or all of the 20 sites.

Alternatives

Alternatives will include the no action alternative, and all proposals received in response to the RFPs. Each alternative will be identified and fully examined. The DEIS will not contain a preferred alternative(s).

Scoping Process

Pursuant to the National Environmental Policy Act of 1969, as amended, (NEPA), a Scoping process will be conducted. As part of this process, public meetings will be held in Arizona and California to identify issues of concern for analysis during the NEPA process. Information packets containing a description of each site will be available during the meetings. Copies of the Phase I Environmental Site Assessments will be made available upon written request. During the preparation of the DEIS, there will be numerous opportunities for public involvement. The meetings, locations, dates and times will be well publicized in the local newspaper of record in the affected communities adjacent to the potential sites. Meetings will be held to allow interested persons to voice their concerns on the scope and significant issues to be examined as part of the NEPA process.

The Scoping process is being held to provide for timely public comments and understanding of Federal plans and programs with possible environmental consequences as required by NEPA and the National Historic Preservation Act of 1966.

DEIS Preparation

Public notice will be given in the Federal Register and the local newspaper of record concerning the availability of the DEIS for public review and comment.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.

Effective underground coal mine ventilation is necessary to protect against mine fires and explosions. Fresh air is coursed throughout the mine ventilation system to prevent asphyxiation of the miners from methane, carbon dioxide, carbon monoxide, and other gases commonly encountered in coal mines. Ventilation is the primary method of controlling miners' exposure to respirable dust and preventing the development of pneumoconiosis (black lung disease). In enacting Section 303(a) of the Mine Act, Congress expressly recognized these and related dangers associated with inadequate ventilation.

II. Desired Focus of Comments

Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the proposed extension of the information collection related to the Ventilation Plans, Tests, and Examinations in Underground Coal Mines, pending approval of the proposed rule on Plan Verification. MSHA is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

A copy of the proposed information collection request may be viewed on the Internet by accessing the MSHA Home Page (http://www.msha.gov) and selecting “Statutory and Regulatory Information” then “Paperwork Reduction Act Submissions (http://www.msha.gov/regspwork.htm)”, or by contacting the employee listed above in the FOR FURTHER INFORMATION CONTACT section of this notice for a hard copy.

III. Current Actions

Underground coal mines are harsh, hostile, and deadly working environments. The ventilation system is one of the most vital life support systems in underground mining. An effective ventilation system is essential for maintaining a safe and healthful working environment. Ventilation related problems in underground coal mines have resulted in thousands of fatalities from explosions, fires and asphyxiation. In addition, the debilitating occupational lung diseases, black lung and silicosis, are controlled by ventilation practices.

An underground mine is a maze of tunnels that must be adequately ventilated with fresh air to provide a safe environment for miners. Methane, a colorless, odorless explosive gas, is liberated from the coal strata. Other noxious gases and dusts from mining and blasting may be present. These explosive and noxious gases and dusts must be diluted, rendered harmless, and carried out of the mine by the ventilating currents. Sufficient air must be provided to maintain the air quality and dust concentrations in accordance with MSHA standards. Mechanical ventilation equipment of sufficient capacity must operate at all times while miners are in the mine. The mining environment is constantly changing as new openings are excavated, roof falls close entries, water collects and restricts openings, etc. Due to this constantly changing environment, frequent tests and examinations are necessary to ensure the integrity of the ventilation system and to detect any changes that may require adjustments in the system. Records of tests and examinations are necessary to ensure that the ventilation system is being maintained and that changes which could adversely affect the integrity of the system or the safety of the miners are not occurring. These examination requirements of 75.360 through 75.364 also incorporate examinations of other critical aspects of the underground work environment such as roof conditions and electrical equipment which have historically caused numerous fatalities.

Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

In accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2) and implementing regulation 41 CFR 101.6, the National Archives and Records Administration (NARA) announces a meeting of the Advisory Committee on Preservation. NARA uses the Committee's recommendations on NARA's implementation of strategies for preserving the permanently valuable records of the Federal Government.

Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that a meeting of the Combined Arts Advisory Panel, Design section (Access, Education and Heritage/Preservation categories), to the National Council on the Arts will be held from October 5-6, 2000 in Room 716 at the Nancy Hanks Center, 1100 Pennsylvania Avenue, NW., Washington, DC, 20506. A portion of this meeting, from 11 a.m. to 12 p.m. on October 6th, will be open to the public for policy discussion and guidelines review.

The remaining portions of this meeting, from 9 a.m. to 6 p.m. on October 5th, and from 9-11 a.m. and 12-2:45 p.m. on October 6th, are for the purpose of Panel review, discussion, evaluation, and recommendation on applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency by grant applicants. In accordance with the determination of the Chairman of May 12, 2000, these sessions will be closed to the public pursuant to (c)(4)(6) and (9)(B) of section 552b of Title 5, United States Code.

Any person may observe meetings, or portions thereof, of advisory panels that are open to the public, and, if time allows, may be permitted to participate in the panel's discussions at the discretion of the panel chairman and with the approval of the full-time Federal employee in attendance.

If you need special accommodations due to a disability, please contact the Office of AccessAbility, National Endowment for the Arts, 1100 Pennsylvania Avenue, NW., Washington, DC 20506, 202/682-5532, TDY-TDD 202/682-5496, at least seven (7) days prior to the meeting.

Further information with reference to this meeting can be obtained from Ms. Kathy Plowitz-Worden, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC, 20506, or call 202/682-5691.

The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of an amendment to Facility Operating License No. NPF-62 issued to AmerGen Energy Company, LLC (the licensee) for operation of the Clinton Power Station (CPS) located in DeWitt County, Illinois.

The proposed amendment along with associated exemption requests would revise the Technical Specification reactor vessel pressure/temperature limits for CPS.

Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act) and the Commission's regulations.

The Commission has made a proposed determination that the amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

Does the change involve a significant increase in the probability of occurrence or consequences of an accident previously evaluated?

The proposed changes to the CPS reactor coolant system (RCS) pressure/temperature (P/T) limits do not modify the boundary, operating pressure, materials or seismic loading of the reactor coolant system. The proposed changes do adjust the P/T limits for radiation effects to ensure that the RPV fracture toughness is consistent with analysis assumptions and NRC regulations. Thus, the proposed changes do not involve a significant increase in the probability of occurrence of an accident previously evaluated.

The proposed changes do not adversely affect the integrity of the reactor coolant pressure boundary such that its function in the control of radiological consequences is affected. Therefore, the proposed changes do not involve a significant increase in the consequences of an accident previously evaluated.

Does the change create the possibility of a new or different kind of accident from any accident previously evaluated?

The proposed changes to the reactor pressure vessel pressure-temperature limits do not affect the assumed accident performance of any structure, system or component previously evaluated. The proposed changes do not introduce any new modes of system operation or failure mechanisms. Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.

Does the change involve a significant reduction in a margin of safety?

The methodology for determining the RPV/RCS P/T limits ensures that the limits provide a margin of safety to the conditions at which brittle fracture may occur. The methodology is based on requirements set forth in Appendix G and Appendix H of 10 CFR 50, with reference to the requirements and guidance of ASME Section XI, and on guidance provided in Regulatory Guide 1.99, Revision 2. The P/T limits currently specified in the CPS Technical specification are based on this methodology, as previously approved via Amendments 51 and 109 to the CPS Operating License. The revised P/T limits are also based on this methodology except as modified by application of the noted Code Cases (in addition to the change in the fluence value and beltline material assumed for analysis).

Although the Code Cases constitute relaxation from the current requirements of 10 CFR 50 Appendix G, the alternatives allowed by the Code are based on industry experience gained since the inception of the 10 CFR 50 Appendix G requirements for which some of the requirements have now been determined to be excessively conservative. The more appropriate assumptions and provisions allowed by the Code Cases maintain a margin of safety that is consistent with the intent of 10 CFR 50 Appendix G, i.e., with regard to the margin originally contemplated by 10 CFR 50 Appendix G for determination of RPV/RCS P/T limits. On this basis, the proposed changes do not involve a significant reduction in the margin of safety.

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.

Normally, the Commission will not issue the amendment until the expiration of the 30-day notice period. However, should circumstances change during the notice period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility, the Commission may issue the license amendment before the expiration of the 30-day notice period, provided that its final determination is that the amendment involves no significant hazards consideration. The final determination will consider all public and State comments received. Should the Commission take this action, it will publish in the Federal Register a notice of issuance and provide for opportunity for a hearing after issuance. The Commission expects that the need to take this action will occur very infrequently.

Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this Federal Register notice. Written comments may also be delivered to Room 6D59, Two White Flint North, 11545 Rockville Pike, Rockville, Maryland, from 7:30 a.m. to 4:15 p.m. Federal workdays. Copies of written comments received may be examined at the NRC Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC.

The filing of requests for hearing and petitions for leave to intervene is discussed below.

By October 19, 2000, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR Part 2. Interested persons should consult a current copy of 10 CFR 2.714 which is available at the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, and accessible electronically through the ADAMS Public Electronic Reading Room link at the NRC Web site (http://www.nrc.gov). If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or an Atomic Safety and Licensing Board, designated by the Commission or by the Chairman of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the designated Atomic Safety and Licensing Board will issue a notice of hearing or an appropriate order.

As required by 10 CFR 2.714, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following factors: (1) The nature of the petitioner's right under the Act to be made party to the proceeding; (2) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (3) the possible effect of any order which may be entered in the proceeding on the petitioner's interest. The petition should also identify the specific aspect(s) of the subject matter of the proceeding as to which petitioner wishes to intervene. Any person who has filed a petition for leave to intervene or who has been admitted as a party may amend the petition without requesting leave of the Board up to 15 days prior to the first prehearing conference scheduled in the proceeding, but such an amended petition must satisfy the specificity requirements described above.

Not later than 15 days prior to the first prehearing conference scheduled in the proceeding, a petitioner shall file a supplement to the petition to intervene which must include a list of the contentions which are sought to be litigated in the matter. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner shall provide a brief explanation of the bases of the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. Petitioner must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to file such a supplement which satisfies these requirements with respect to at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing, including the opportunity to present evidence and cross-examine witnesses.

If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held.

If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment.

If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.

A request for a hearing or a petition for leave to intervene must be filed with the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, or may be delivered to the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, by the above date. A copy of the petition should also be sent to the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to Kevin P. Gallen, Morgan, Lewis & Bockius LLP, 1800 M Street, NW., Washington, DC 20036-5869, attorney for the licensee.

Nontimely filings of petitions for leave to intervene, amended petitions, supplemental petitions and/or requests for hearing will not be entertained absent a determination by the Commission, the presiding officer or the presiding Atomic Safety and Licensing Board that the petition and/or request should be granted based upon a balancing of the factors specified in 10 CFR 2.714(a)(1)(i)-(v) and 2.714(d).

For further details with respect to this action, see the application for amendment dated August 25, 2000, which is available for public inspection at the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, and accessible electronically through the ADAMS Public Electronic Reading Room link at the NRC Web site (http://www.nrc.gov)

The U.S. Nuclear Regulatory Commission (the Commission) is considering issuance of amendments to Facility Operating License Nos. DPR-38, DPR-47, and DPR-55, issued to the Duke Energy Corporation (the licensee), for operation of the Oconee Nuclear Station, Units 1, 2, and 3, respectively, located in Seneca, South Carolina.

The proposed amendment would revise Technical Specification (TS) Surveillance Requirement (SR) 3.8.1.9.a as it relates to the annual test of the Keowee Hydro Units (KHUs) by adding a Note stating: “The upper limits on frequency and voltage are not required to be met until the NRC issues an amendment that removes this Note (license amendment request to be submitted no later than April 5, 2001).”

The present annual SR requires verification on an actual or simulated emergency actuation signal that each KHU automatically starts and achieves an output frequency ≥ 57 Hertz (Hz) and ≤ 63 Hz and an output voltage ≥ 13.5 kilo-volts (kV) and ≤ 14.49 kV in ≤ 23 seconds. Currently, when a KHU is started, it reaches rated frequency and voltage within the required 23 seconds. However, due to the physical characteristics of the KHU, its speed continues to increase, causing the frequency to exceed the limits specified in SR 3.8.1.9.a for a short period of time. Following this brief overshoot, the frequency returns to within the limits specified in SR 3.8.1.9.a. This is consistent with the way the KHUs have been operated since initial licensing and complies with the licensee's interpretation of the SR.

As a result of recent discussions with the NRC, it became clear that interpretation differences existed between the staff and the licensee concerning this SR. The staff interpreted the SR to imply that the limits on frequency and voltage constitute upper and lower limits for operation of the KHUs. In a telephone conference call on September 5, 2000, the staff informed the licensee of this interpretation, and that Oconee Nuclear Station, Units 1, 2 and 3, were not in compliance with TS 3.8.1 because the frequency briefly exceeded the upper limit specified in the SR in response to an actual or simulated emergency actuation signal. The licensee stated that this would require declaring the KHUs inoperable, entry into TS 3.0.3, and shutdown of the three units. Therefore, the licensee requested that a Notice of Enforcement Discretion (NOED) be granted pursuant to the NRC's policy regarding exercise of discretion for an operating facility, set out in Section VII.c, of the “General Statement of Policy and Procedures for NRC Enforcement Actions” (Enforcement Policy), NUREG-1600, and be effective until such time as the staff approves an amendment modifying the SR, which was submitted on September 7, 2000. The staff granted the NOED on September 5, 2000, and, as a result, is processing this amendment under exigent circumstances in accordance with the NRC's policy regarding exercising of enforcement discretion.

Before issuance of the proposed license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act) and the Commission's regulations.

Pursuant to 10 CFR 50.91(a)(6), for amendments to be granted under exigent circumstances, the NRC staff must determine that the amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below:

Pursuant to 10 CFR 50.91, Duke Power Company (Duke) has made the determination that this amendment request involves a No Significant Hazards Consideration by applying the standards established by the NRC regulations in 10 CFR 50.92. This ensures that operation of the facility in accordance with the proposed amendment would not:

1. Involve a significant increase in the probability or consequences of an accident previously evaluated.

No. The License Amendment Request (LAR) involves adding a note to Surveillance Requirement (SR) 3.8.1.9[.a] to waive the surveillance requirements associated with the upper limits for KHU voltage and frequency. The waiver of these requirements will allow Duke to avoid an unplanned forced shutdown of all three Oconee units, and the potential safety consequences and operational risks associated with that action. It will also provide an opportunity for Duke to work with the NRC to resolve any technical concerns.

This LAR involves an interpretation issue, rather than the inability of the KHU to perform its intended safety function.

Waiving the requirements to meet the upper voltage and frequency limits associated with SR 3.8.1.9.a does not involve: (1) A physical alteration to the Oconee Units; (2) the installation of new or different equipment; (3) operating any installed equipment in a new or different manner; or (4) a change to any set points for parameters which initiate protective or mitigative action.

There is no adverse impact on containment integrity, radiological release pathways, fuel design, filtration systems, main steam relief valve set points, or radwaste systems. No new radiological release pathways are created.

Therefore, the probability or consequences of an accident previously evaluated is not significantly increased.

2. Create the possibility of a new or different kind of accident from any accident previously evaluated.

No. The LAR involves adding a note to allow for a temporary waiver of [the upper voltage and frequency limits of] SR 3.8.1.9.a associated with the KHUs.

Waiver of this surveillance requirement does not involve a physical effect on the unit, nor is there any increased risk of a unit trip or reactivity excursion. No new failure modes or credible accident scenarios are postulated from this activity.

Therefore, the possibility of a new or different kind of accident from any kind of accident previously evaluated is not created.

3. Involve a significant reduction in a margin of safety.

No. The LAR involves adding a note to allow waiver of the requirements to meet [the upper voltage and frequency limits of] SR 3.8.1.9.a. Temporarily waiving the requirement to meet this [upper voltage and frequency limits of this] SR will allow Duke to avoid an unplanned forced shutdown of all three Oconee Units and the potential safety consequences and operational risks associated with that action. It will also allow Duke the opportunity to work with the NRC to resolve any technical concerns.

Temporarily waiving the requirement to meet the upper voltage and frequency limits associated with SR 3.8.1.9.a does not involve: (1) A physical alteration of the Oconee Units; (2) the installation of new or different equipment; (3) operating any installed equipment in a new or different manner; (4) a change to any set points for parameters which initiate protective or mitigative action; or (5) any impact on the fission product barriers or safety limits.

Therefore, this request does not involve a significant reduction in a margin of safety.

The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.

The Commission is seeking public comments on this proposed determination. Any comments received within 14 days after the date of publication of this notice will be considered in making any final determination.

Normally, the Commission will not issue the amendment until the expiration of the 14-day notice period. However, should circumstances change during the notice period, such that failure to act in a timely way would result, for example, in derating or shutdown of the facility, the Commission may issue the license amendment before the expiration of the 14-day notice period, provided that its final determination is that the amendment involves no significant hazards consideration. The final determination will consider all public and State comments received. Should the Commission take this action, it will publish in the Federal Register a notice of issuance. The Commission expects that the need to take this action will occur very infrequently.

Written comments may be submitted by mail to the Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this Federal Register notice. Written comments may also be delivered to Room 6D59, Two White Flint North, 11545 Rockville Pike, Rockville, Maryland, from 7:30 a.m. to 4:15 p.m. Federal workdays. Copies of written comments received may be examined at the NRC Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC.

The filing of requests for hearing and petitions for leave to intervene is discussed below.

By October 19, 2000, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR Part 2. Interested persons should consult a current copy of 10 CFR 2.714, which is available at the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, and accessible electronically through the ADAMS Public Electronic Reading Room link at the NRC Web site (http://www.nrc.gov). If a request for a hearing or petition for leave to intervene is filed by the above date, the Commission or an Atomic Safety and Licensing Board, designated by the Commission or by the Chairman of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the designated Atomic Safety and Licensing Board will issue a notice of hearing or an appropriate order.

As required by 10 CFR 2.714, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following factors: (1) The nature of the petitioner's right under the Act to be made a party to the proceeding; (2) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (3) the possible effect of any order which may be entered in the proceeding on the petitioner's interest. The petition should also identify the specific aspect(s) of the subject matter of the proceeding as to which petitioner wishes to intervene. Any person who has filed a petition for leave to intervene or who has been admitted as a party may amend the petition without requesting leave of the Board up to 15 days prior to the first prehearing conference scheduled in the proceeding, but such an amended petition must satisfy the specificity requirements described above.

Not later than 15 days prior to the first prehearing conference scheduled in the proceeding, a petitioner shall file a supplement to the petition to intervene which must include a list of the contentions which are sought to be litigated in the matter. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner shall provide a brief explanation of the bases of the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. Petitioner must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to file such a supplement which satisfies these requirements with respect to at least one contention will not be permitted to participate as a party.

Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing, including the opportunity to present evidence and cross-examine witnesses.

If the amendment is issued before the expiration of the 30-day hearing period, the Commission will make a final determination on the issue of no significant hazards consideration. If a hearing is requested, the final determination will serve to decide when the hearing is held.

If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment.

If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.

A request for a hearing or a petition for leave to intervene must be filed with the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, or may be delivered to the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, by the above date. A copy of the petition should also be sent to the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to Anne W. Cottington, Winston and Strawn, 1200 17th Street, NW., Washington, DC 20005, attorney for the licensee.

Nontimely filings of petitions for leave to intervene, amended petitions, supplemental petitions and/or requests for hearing will not be entertained absent a determination by the Commission, the presiding officer or the presiding Atomic Safety and Licensing Board that the petition and/or request should be granted based upon a balancing of the factors specified in 10 CFR 2.714(a)(1)(i)-(v) and 2.714(d).

For further details with respect to this action, see the application for amendment dated September 7, 2000, which is available for public inspection at the Commission's Public Document Room, the Gelman Building, 2120 L Street, NW., Washington, DC, and accessible electronically through the AD